Total 6 Director/C-Level Quality Assurance / Control job vacancies in Fort McNair, District of Columbia

As a Financial Compliance Manager (Chief, Office of Compliance), you will:

• Direct and monitor the Bureau's internal control, product accountability, and internal quality audit program to provide reasonable assurance that assets are safeguarded from loss, misuse, or misappropriation, and to ensure conformance with the Bureau's quality management system.
• Oversee the planning and conducting of independent reviews of Bureau organizations, programs, systems and activities to assess the adequacy of and to improve internal controls and compliance with internal and external control-related requirements.
• Provide monthly and other periodic reports to executive level management in the Bureau regarding outstanding corrective actions and controls reviews.
• Serve as a member, Ex Officio, on the Bureau's executive level Internal Control Policy Committee (ICPC) and advise ICPC regarding internal control and audit related issues.
• Perform such human resources functions as interviewing staff, resolving employee complaints, effecting disciplinary measures, initiating personnel actions and training, developing staff (e-performance and workforce analysis), and supporting affirmative action programs that are typical of Office Chief positions in BEP.

As an IT Specialist (Policy/Planning) (Division Director Capital Planning and Investment Control), you will:

• Have the primary leading role in the management of the Capital Planning and investment Control (CPIC) program, guiding and overseeing the selection, control, and evaluation of IT investments through the Agency's CPIC process.
• Act as the expert IT administrative subject matter expert and demonstrates proficiency in the areas of program establishment and implementation.
• Serve as the OCIO spokesperson regarding IT administrative issues to external interest groups, media, contracting officials, vendor, and high-level technical staff.
• Produce decision-oriented work products that are often findings and recommendations that may be of major significance to senior management.

As Principal Deputy Director, Office of Human Resources, you will:

• serve as full partner with the Director, OHR in exercising responsibility for the overall technical and administrative management of human capital and human resources programs and operations, including ethics and compliance.
• support Director, OHR and the organization in the "One CDC" initiative including strategic alignment and governance, operating model transformation, workforce planning and data analytics, automation and technology, process optimization, communications, and change management.
• assist in leading and advancing technology efforts and business process principles to improve human capital programs and operations that support a model human capital organization and strategic goals.
• design and maintain state-of-the-art HR programs and policies by working with internal and external customers and stakeholders to identify and keep abreast of emerging HR developments and best practices.
• direct the development and delivery of a comprehensive, integrated set of strategies, policies, programs, and systems to evaluate and manage HR resources consistent with short- and long-term modernization initiatives.
• serve as a principal advisor to the organizations' leadership on matters related to human resources management and human resources provided by the office.
• optimize use of organization's resources to achieve organization goals and objectives as well as the customer's needs.
• represent the office with a variety of internal and external organizations performing review and oversight of human resources activities.

We strongly encourage applicants to read the entire announcement before submitting their applications.

As the Director, Identity Assurance you are responsible for providing executive leadership and direction in the establishment and maintenance of a Service-wide strategy that ensures consistent oversight of all authentication and authorization needs across IRS functions and programs, ensuring the establishment of a secure environment for taxpayers to interact with the IRS.

As the Director Identity Assurance your duties and responsibilities include the following:

• Serves as consultant and principal advisor to senior management on all matters relating to identity assurance needs across IRS functions and programs. Provides executive leadership and direction through coordination with top-level heads of office. Formulates short and long-range program policies, strategies, and objectives for identity assurance efforts throughout the IRS. Manages a broad set of activities to enhance identity assurance and digital identity services related to federal tax matters. Coordinates program activities with other top-level IRS executives to prepare Service-wide policies, address cross-functional issues, new identity assurance strategies, and ensure consistency of approach. Provides strategic direction for the development and publication of policies and procedures regarding identity assurance including procedures for initiating new and/or enhanced services and for defining stakeholder roles and responsibilities and governance processes.
• Directs activities to build leveraged partnerships and collaborate with internal and external partners and stakeholders to provide organizational support and strategically deliver value-added, cost-efficient business and technology solutions. Provides executive oversight of the Digital Identity Risk Assessment process that defines the identity level of assurance and risk mitigations for IRS public facing applications. Provides executive leadership to design, develop, and implement the strategic vision for enhanced identity assurance. Collaborates with senior IRS executives to align people, processes, and technology initiatives to achieve this strategic vision and continuously monitor performance, identify risks and weaknesses, while also preserving the IRS's reputation as a premier governmental steward of private taxpayer data. Briefs all levels of IRS management as well as external stakeholders on IRS identity assurance developments. Prepares input to testimony and may participate in Congressional hearings related to IRS identity assurance matters.
• Leads development of business requirements for identity assurance, including the development and prioritization of business justifications and the establishment and monitoring of performance measures for initiatives. Assesses taxpayer needs, capabilities, and expectations to determine appropriate channels for optimal service delivery. Collaborates with the Chief Privacy Officer and other senior IRS executives to generate, develop, prioritize, and execute the portfolio of identity assurance activities/services/mitigations. Manages and chairs Advisory/Executive Steering Committee(s) that are composed of stakeholders from across IRS and responsible for oversight of the development of identity assurance program.
• Partners with other federal agencies, private industry, and international organizations to stay current with new technologies and assess trends and related practices in the identity assurance industry and evolving patterns in taxation. Consults with the Chief Privacy Officer in the design and implementation of security measures (standards and systems) to ensure the measures comply with policy and legal requirements and provides effective protection of taxpayer privacy. Partners with internal organizations, such as Records Management and Disclosure, to coordinate privacy aspects of regulatory adherence to email, instant message and other electronic files management policies and the control of sensitive information. Partners with Information Technology and Cybersecurity to develop and deploy innovative technologies to ensure a secure environment for taxpayers to interact with IRS.
• Ensures Service-wide adherence with identity assurance principles and National Institute of Standards and Technology's (NIST) digital identity guidelines technical requirements through a robust risk assessment process that looks at business processes for risks to identity assurance. Regularly assesses all applicable controls to the current environment identifying gaps and mitigations. Collaborates across IRS business units, functional units, and senior executive leadership to develop and implement identity assurance to increase operational efficiency and reduce taxpayer burden.

WHERE CAN I FIND OUT MORE ABOUT OTHER IRS CAREERS? If you want to find out more about IRS careers, visit us on the web at www.jobs.irs.gov

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As Associate Director Clinical QA, you will be trusted to provide input and assist in establishing the vision and strategic direction for Clinical R&D activities in the R&D, QA, GCP, GLP and Medical Safety Operations Groups at our Main Campus in Fort Worth, TX.

POSITION PURPOSE

• Provides input and assist in establishing the vision and strategic direction for Clinical R&D activities as part of the R&D QA GCP, GLP and Medical Safety Operations Group.
• Provides Clinical QA oversight to ensure that global Clinical Operations activities conducted by Alcon for its medical devices and pharmaceutical products are in compliance with applicable regulations, guidelines and/ or quality standards.
• Manages the Good Clinical Practice (GCP) audit program across all Alcon franchises to assure clinical related activities are conducted according to Alcon and quality standards and applicable regulations with high degree independence.  

In this role, a typical day will include:

• Provides leadership and sound business ethics in the interpretation and implementation of global GxP compliance programs, computer system and/or software validation and related services and compliance training while ensuring Clinical QA independent assessments.
• Supports clinical research and development activities for all Alcon franchises and Technology Platforms to maximize standardization and compliance.
• Advises senior management of the need for corrective and preventive actions with a key advisory role in the development of action plans and monitoring of effectiveness of action plans as a result of internal and/or external Regulatory audits.
• Ensures senior management awareness of compliance issues impacting regulatory acceptability, by appropriately escalating as per quality risk management.
• Provides support to relevant functions on proper identification and escalation of quality related issues.
• Trends, interprets and presents compliance data and metrics according to worldwide legal and regulatory requirements and Alcon standards.
• Drives/facilitates projects in collaboration with stakeholders to evaluate and or implement quality/compliance improvement initiatives.
• Leads or support cross-functional teams to evaluate impact of process changes to systems and related processes, to research best practices, determine solutions and manage change.
• Develops unique approaches to promote and instill a culture of quality and compliance.
• Provides coaching, and aid in the development of RDQA Clinical staff and business partners.
• Provides consultation and education including, but not limited to interpretation of global regulations and guidelines such as GCP, US FDA EU MDR, ISO Standards, etc.
• Authors or reviews & approves documentation including but not limited to audit schedule, plans and reports, documents associated with regulatory submissions, notes to file, study protocols, document templates, plans and reports, and clinical evaluation documents.
• Leads and supports the investigation of deviations and other quality issues detected from any source e.g., monitoring and data management, trends, signals, etc. 
• Provides guidance, review, and approval of associated deviations (NCI, CAPAs and Actions) and evaluates effectiveness.
• Provides R&D QA support to Supplier Evaluation Teams, and function as Clinical SME for service providers.
• Leads audit & inspection preparation, conduct and remediation as needed, for both national and local inspections (e.g., FDA, EMA, MHRA, TUV etc.).
• Contributes to cross-divisional activities including but not limited to FAA, FSCA and/or Market Actions/ Investigational Product Field Actions as assigned.

WHAT YOU'LL BRING TO ALCON:

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs).
• The ability to fluently read, write, understand, and communicate in English.
• 7 Years of Relevant Experience
• 5 Years of Demonstrated Leadership
• Work hours: Exempt
• Travel Requirements: up to 20% as needed.
• Relocation assistance: No
• Sponsorship available: No

PREFERRED QUALIFICATIONS:

• Bachelor’s degree in science or technology.
• QA work experience in a regulated Medical Device / Pharmaceutical Industry.
• Strong R&D experience and knowledge, with manufacturing experience desired.
• Proven personnel management experience.
• Advanced knowledge of ISO 14155/ 14971, 13485, ICH 6, Medical Device and Pharmaceutical EU and FDA 21 CFR 820 / 211 regulatory requirements.
• Highly proficient in MS Office.
• Highly proficient in data analytics, critical thinking, and decision making.
• Proven influencing and negotiating skillset.
• Ability to lead virtual teams and function in a matrix organization, with project management experience desired.
• Advocate for exceptional Quality and Compliance Standards - does not compromise on customer expectations and regulatory requirements.

HOW YOU CAN THRIVE AT ALCON:

• Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
• Alcon provides robust benefits package including health, life, retirement, flexible time off, and much more!

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

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Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.

Your opportunity

IQVIA, a leading Human Data Science company, is seeking a dynamic and experienced Senior Director of Compliance to join our Ethics and Compliance Office (ECO). In this critical leadership role, you will shape and maintain an effective healthcare compliance program on a global scale. Your responsibilities will span a wide range of duties, ensuring adherence to ethical standards and regulatory requirements.

You will interact regularly with various internal stakeholders, including Legal, Finance, Human Resources, Internal Audit, Global Quality Assurance, Chief Information Office, and all global and regional business units, as well as with external parties such as auditors, law firms, and regulators. 

As a leader, you will be a trusted member of the ECO Leadership Team, managing at least one employee and reporting to the Chief Compliance Officer, and driving a culture of ethics and integrity in all we do.

Your key responsibilities will include:

Strategic Leadership:

• Oversee IQVIA’s Code of Conduct and ethics and compliance policies.

• Manage the Ethics Line, including the Ethics Line mailbox, in accordance with applicable laws and best practices.

• Prepare materials for presentations to IQVIA’s senior leadership, Audit Committee, and external auditors.

• Provide expert guidance to internal stakeholders across Legal, Finance, Human Resources, and other departments.

• Conduct sensitive investigations as needed.

Collaboration and Stakeholder Management:

• Interact regularly with internal teams, including Legal, Finance, Internal Audit, and Global Quality Assurance.

• Build collaborative relationships with external parties such as auditors, law firms, and regulators.

People Leadership:

• Manage at least one employee.

• Report directly to the Chief Compliance Officer.

• Drive a culture of ethics and integrity throughout the organization.

To be successful on this role, you will have qualifications such as:

• Subject Matter Expertise:

  • Stay informed about global laws, regulations, and codes of ethics.

  • Provide guidance to leadership, management, and employees.

  • JD preferred, or Masters’ degree in legal relevant area, and at least 10 years of relevant experience.

  • Sound knowledge and understanding of the legal and regulatory environment in which the company operates; life sciences or healthcare compliance expertise.

• Ethics Line Management:

  • Experience managing an ethics reporting line, maintaining data and analytics, and preparing accurate, compelling presentations for a wide range of audiences including executive leadership, Audit Committee of Board of Directors, external auditors, and regulators in different regions and countries.

  • Ensure compliance with EU whistleblower laws and other relevant regulations.

• Risk Assessment:

  • Utilize deep subject matter knowledge to assess risks across various areas.

  • Experience managing Codes of Conduct and corporate policies.

  • Experienced investigator; able to guide investigations and enhance capabilities for various resources who do not regularly conduct investigations.

  • Excellent analytical and problem-solving skills; ability to synthesize and summarize complex issues.

  • Excellent judgment and discretion, including the ability to handle sensitive and/or confidential information.

You will differentiate yourself if you have:

• Relevant compliance or professional certification: Certified Compliance and Ethics Professional (CCEP), Certified Fraud Examiner (CFE).

• Life sciences outsourcing experience (e.g., CRO).

Location

• IQVIA currently offers remote work arrangements.

• The incumbent must be based anywhere on the East Coast of the United States.

How to Apply

If you are a seasoned compliance professional with a passion for ethics and integrity, we invite you to be part of our mission to advance healthcare through data science. Apply now by visiting our careers page and searching for Job ID R1393190.

We look forward to welcoming a dedicated leader to our team! 🌟

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status