Senior Manager, Quality Assurance in Medical Affairs
4 weeks ago
Company Overview
Allergan is dedicated to discovering and delivering innovative solutions that address significant health challenges today and in the future.
Our commitment is to make a meaningful impact on patients' lives across various therapeutic areas, including immunology, oncology, neuroscience, and eye care, along with our offerings in the Allergan Aesthetics portfolio.
Position Summary
The Senior Manager of Quality Assurance in Medical Affairs is tasked with ensuring independent quality oversight of GxP activities conducted by Allergan's Medical Affairs division. This includes, but is not limited to, non-interventional studies, medical information, and other regulatory obligations pertaining to Allergan's pharmaceutical, device, and cosmetic products.
This role reports directly to the Director of Safety, Vigilance, and Medical Affairs Quality Assurance.
Key Responsibilities
- Ensure quality and compliance within a regulated environment, adhering to global and local regulations, as well as Allergan's policies and procedures, through the review of compliance and quality system data.
- Lead or engage in strategic initiatives aimed at enhancing compliance with regulatory standards, positioning Allergan for future success.
- Contribute to a comprehensive quality assurance framework for Medical Affairs, encompassing both internal and vendor-managed activities.
- Collaborate with Medical Affairs and Epidemiology to implement a balanced quality assurance oversight model for non-interventional studies and regulatory commitments.
Advancement of Quality Systems
- Drive the evolution of the Allergan Quality System by participating in the development and execution of necessary systems and processes to support global quality assurance, ensuring quality is integrated throughout all stages of process development.
Qualifications
- A Bachelor's Degree in a technical or scientific discipline (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience (minimum of 8 years) with substantial exposure to the pharmaceutical, medical device, or related industries.
- A solid technical background with a comprehensive understanding of the audit process and extensive knowledge of global GMP regulations related to quality systems and compliance.
- Familiarity with various quality and operational systems that support product design, development, production, and distribution, alongside an understanding of quality management principles.
Personal Attributes
- Essential personal skills include strong interpersonal abilities, leadership qualities, maturity, decisiveness, and sound judgment.
- Effective communication skills are crucial, with the ability to collaborate efficiently across different divisions and technical areas.
Experience
- A minimum of 6 years in Quality Assurance, with some management experience preferred, along with an additional 3 years in another role within the pharmaceutical or medical device industry. Experience in compliance, auditing, or regulatory affairs is advantageous.
Commitment to Diversity
Allergan is committed to fostering an inclusive workplace that values diversity and ensures equal opportunity for all qualified individuals, free from discrimination based on race, color, religion, national origin, age, sex, disability, or any other legally protected status.
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