Total 4 Director/C-Level Quality Assurance / Control job vacancies in Fort Meade, South Dakota

Package Description: At Avery Healthcare we believe in caring for those who care for our residents; We recognise and celebrate our hard-working colleagues, supporting your career development, offer a variety of apprenticeships, and provide you with access to a range of leisure and retail discounts. We are now seeking a compassionate, experienced and dedicated individual to join our friendly, award-winning team as an Associate Director of Quality based in our Central & South West Division. About The Role The role of Associate Director of Quality offers a fantastic opportunity within Avery Healthcare to ensure the exceptional standards of care delivery and quality services for our residents, relatives, and colleagues. Reporting to the Director of Quality and working with the Operational teams you will develop a culture that values the highest standards of care, safety, quality, and clinical risk. Leading by example, you will provide Leadership and take responsibility for ensuring robust quality assurance systems and processes, ensuring group quality indicators and regulatory requirements are fully satisfied and therefore ensuring that safe, quality care is delivered to residents. Our people are invaluable to us and for the future success of the business, you will inspire, coach, and develop a team of direct reports to take full accountability for ongoing development. Working with senior colleagues to drive continuous improvement, you will lead change and challenge conventional approaches, to create a learning organisation, offering expert advice on regulatory requirements, new services, and projects. Supporting the Director of Quality, you will provide professional nursing leadership and advice, supporting with any learning required. The health and wellbeing of everyone in our organisation is of the upmost importance to us so taking on the role of Infection Prevention Control lead, you will ensure that all policies are fit for purpose and up to date. This rewarding role includes an attractive salary package, including performance incentives, travel expenses and benefits. About You You will lead by example, driving our vision to offer exceptional care and experience whilst establishing ourselves as the preferred choice for residents and employees, creating meaningful lives together. You will live our values of caring, supportive, honest, respectful, and accountable in all that you do. To be successful in your application, you must: Be a 1st level Registered Nurse (nursing home) with current NMC number Have a minimum of 5 years experience in a Care & Quality role and be able to evidence experience of change management and impact Have proven experience in a leadership role, having managed a team successfully to deliver objectives Have a good knowledge of the regulatory framework Have the knowledge and understanding to analyse and interpret data to identify emerging risks, themes and trends and work with operational teams to identify practicable solutions Have the personal qualities to work with others, influence, negotiate and develop strong working relationships. Please note this role will require: Proof of eligibility to work in the UK A clear and enhanced DBS Disclosure check, the cost of which will be met by Avery

Package Description: At Avery Healthcare we believe in caring for those who care for our residents; We recognise and celebrate our hard-working colleagues, supporting your career development, offer a variety of apprenticeships, and provide you with access to a range of leisure and retail discounts. We are now seeking a compassionate, experienced and dedicated individual to join our friendly, award-winning team as an Associate Director of Quality based in our Central & South West Division. About The Role The role of Associate Director of Quality offers a fantastic opportunity within Avery Healthcare to ensure the exceptional standards of care delivery and quality services for our residents, relatives, and colleagues. Reporting to the Director of Quality and working with the Operational teams you will develop a culture that values the highest standards of care, safety, quality, and clinical risk. Leading by example, you will provide Leadership and take responsibility for ensuring robust quality assurance systems and processes, ensuring group quality indicators and regulatory requirements are fully satisfied and therefore ensuring that safe, quality care is delivered to residents. Our people are invaluable to us and for the future success of the business, you will inspire, coach, and develop a team of direct reports to take full accountability for ongoing development. Working with senior colleagues to drive continuous improvement, you will lead change and challenge conventional approaches, to create a learning organisation, offering expert advice on regulatory requirements, new services, and projects. Supporting the Director of Quality, you will provide professional nursing leadership and advice, supporting with any learning required. The health and wellbeing of everyone in our organisation is of the upmost importance to us so taking on the role of Infection Prevention Control lead, you will ensure that all policies are fit for purpose and up to date. This rewarding role includes an attractive salary package, including performance incentives, travel expenses and benefits. About You You will lead by example, driving our vision to offer exceptional care and experience whilst establishing ourselves as the preferred choice for residents and employees, creating meaningful lives together. You will live our values of caring, supportive, honest, respectful, and accountable in all that you do. To be successful in your application, you must: Be a 1st level Registered Nurse (nursing home) with current NMC number Have a minimum of 5 years experience in a Care & Quality role and be able to evidence experience of change management and impact Have proven experience in a leadership role, having managed a team successfully to deliver objectives Have a good knowledge of the regulatory framework Have the knowledge and understanding to analyse and interpret data to identify emerging risks, themes and trends and work with operational teams to identify practicable solutions Have the personal qualities to work with others, influence, negotiate and develop strong working relationships. Please note this role will require: Proof of eligibility to work in the UK A clear and enhanced DBS Disclosure check, the cost of which will be met by Avery

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.

Job Description:

The Associate Director of Gift Compliance (“the AD”) contributes to Brown’s Advancement efforts by enabling and guiding fundraising staff through the process of developing, processing, and finalizing donor gift documentation. As a subject matter expert and service provider, the AD prioritizes instruction and efficient service for both staff and donors. Knowledge and application of federal laws, state regulations, and University policies is essential and the AD seeks to reflect these appropriately in written gift documentation. Interacting with Divisional and University leadership to put forward key fundraising milestones for Corporation approval is a recurring and vital part of the AD’s role. They also manage the team responsible for gift documentation services and in that capacity provide regular, routine training opportunities to promote broad knowledge and understanding amongst fundraising staff. In support of these efforts, the AD leverages their technical knowledge, data skills, and cross-team collaboration to continuously drive systematic process improvements resulting in an operation that is modern, efficient, and regarded as an organizational strength.

Brown University is committed to advancing diversity, inclusion, and equity and an Affirmative Action/Equal Opportunity Employer.

Education and Experience

• Bachelor’s degree required.

• Minimum of 5 years of development or related experience, in fields such as non-profits, fundraising, higher education, legal or technical writing

• Minimum of 2 years of supervisory or management experience

Required Qualifications

• Collaborative mindset and relationship-building skills

• Excellent written and oral communication skills, including copy-editing and proofreading

• Strong attention to detail and how the big picture is affected

• Excellent organization and management skills

• Strong analytical skills including demonstrated ability to interpret data and apply it to business decisions

• Basic data management and manipulation skills

• Comfortable learning new technologies coupled with the ability to self-learn

• Proficient knowledge of the MS Office Suite (Word, Excel, PowerPoint) and CRM systems

Job Competencies

• Demonstrated commitment to diversity and inclusion as well as an understanding of the contributions a diverse workforce brings to the workplace. 

• Growth mindset and leadership ability

• Diplomacy, poise, and discretion in dealing with executives and high-level donors

• Creative problem-solving within legal, policy, and political constraints

• Work independently and manage highly complex processes for a high-quality end product  

• Communicate effectively and professionally

• Work well under deadlines

• Collaborate in a team environment

Applicants are asked to submit a cover letter and resume with their application. All offers of employment are contingent upon a completed criminal background check and education verification satisfactory to Brown. 

Recruiting Start Date:

2024-02-20

Job Posting Title:

Associate Director, Gift Compliance

Department:

Advancement

Grade:

Grade 11

Worker Type:

Employee

Worker Sub-Type:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

37.5

Position Work Location:

Hybrid Eligible

Submission Guidelines:

Please note that in order to be considered an applicant for any staff position at Brown University you must submit an application form for each position for which you believe you are qualified. Applications are not kept on file for future positions. Please include a cover letter and resume with each position application.

Still Have Questions?

If you have any questions you may contact employment@brown.edu.

EEO Statement:

Brown University is an E-Verify Employer.

As an EEO/AA employer, Brown University provides equal opportunity and prohibits discrimination, harassment and retaliation based upon a person’s race, color, religion, sex, age, national or ethnic origin, disability, veteran status, sexual orientation, gender identity, gender expression, or any other characteristic protected under applicable law, and caste, which is protected by our University policies.