Total 8 Director/C-Level Quality Assurance / Control job vacancies in Fort Yates, North Dakota

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

Job: Title: Associate Director of Quality Assurance (GCP)

Salary: Competitive

Location: York (Hybrid role)

SRG are supporting a global clinical lab services company in their search for an Associate Director of Quality Assurance.

The successful Quality Assurance Lead will be responsible for implementing strategies to allow successful delivery of high-quality Clinical Trials studies; by driving effective, efficient, global processes across the various aspects of our Quality and Operations.

Responsibilities:

• Work closely with the global QA leadership team to provide regional oversight of the quality assurance team.
• Promote and uphold a high performing culture through effective talent planning, selection, onboarding and continuing education. Curate and deliver comprehensive training plans and materials to foster successful onboarding and employee performance.
• Identify and implement strategies to maintain a culture of quality. Develop and execute holistic audit program, including internal audits, vendor audits, client audits and regulatory inspections, to ensure compliance.
• Leverage industry knowledge to refine our strategies and processes for delivering high quality clinical trials. Maintain working knowledge of industry and regulatory standards and requirements.
• Provide guidance and leadership as it relates to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), MHRA, FDA, data privacy and other regulatory standards as needed or directed. Serve as a responsive escalation point for Clinical Trials quality issues and concerns.
• Oversee and manage vendor management program to ensure supply compliance, computer systems validation program, and data privacy program regionally to ensure compliance.

Requirements:

• Bachelor's Degree required; Master's Degree preferred
• Extensive industrial experience in Quality Assurance, Regulatory Affairs, Laboratory Operations or a related field required.
• Significant experience of progressive leadership experience required.
• Experience managing quality/regulatory department of regional responsibility.
• Experience with data privacy regulations preferred.
• Experience with Medicines & Healthcare products Regulatory Agency (MHRA), Food & Drug Administration (FDA); knowledge of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) strongly preferred.

If you are interested in finding out more, please apply using the provided link or send a copy of your CV directly to Alex Sheridan on or contact Alex directly on 0203 854 5418 for a confidential conversation.

SRG are the UK number 1 recruitment company specialising in the science, engineering, clinical, pharmaceutical, food/FMCG, renewable, biotech, chemicals and medical devices sectors.

As scientists ourselves, our specialist sector knowledge and our passion are second to none. It's this combination that makes us different. We're committed to providing outstanding temporary, contract and permanent career opportunities of all levels for our candidates and a comprehensive range of expert strategic recruitment services for our clients.

If you have a scientific background and this position is not relevant / suitable for you please feel free to get in touch or visit www.srg.co.uk to view our other vacancies.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.