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Senior Quality Assurance Manager, Medical Affairs

3 months ago

Hamilton, Ontario, Canada Allergan Full time

Company Overview

At Allergan, our commitment is to innovate and deliver transformative medical solutions that address significant health challenges today and prepare for those of tomorrow. We aim to positively impact lives across various therapeutic domains, including immunology, oncology, neuroscience, and eye care, alongside our extensive Allergan Aesthetics offerings. For further insights about Allergan, please visit our official website.

Position Overview

The Senior Quality Assurance Manager for Medical Affairs is tasked with providing independent quality oversight for GxP activities conducted within Allergan's Medical Affairs sector. This includes, but is not limited to, non-interventional studies, medical information, and other regulatory obligations, encompassing Allergan's pharmaceutical, device, and cosmetic product lines.

This role reports directly to a Director of Safety, Vigilance, and Medical Affairs Quality Assurance. It is expected that the individual exemplifies leadership and performance standards that align with Allergan's core values.

  • Ensures adherence to quality and compliance standards in a regulated environment, which includes global and local regulations, as well as Allergan's policies and procedures, through the evaluation of compliance and quality system data.
  • Leads or engages in strategic initiatives aimed at enhancing compliance with regulatory standards while positioning Allergan for future success.
  • Contributes to a comprehensive quality assurance framework for Medical Affairs, integrating both internal and vendor-managed activities. Collaborates with Medical Affairs and Epidemiology to implement a balanced quality assurance oversight model for non-interventional studies and regulatory commitments.
  • Encourages ongoing education regarding relevant regulations and expectations for both self and fellow Allergan staff.
  • Advances the Allergan Quality System by participating in the development and execution of systems and processes essential for global quality assurance, ensuring quality is embedded at every stage of process development.
  • Actively participates in and leads GxP inspection activities, providing expert guidance to facilitate successful inspections concerning safety, regulatory affairs, and medical affairs topics.
  • Recognized as a knowledgeable resource for consultation on global Medical Affairs and non-interventional research regulations and corporate policies, particularly in relation to CAPA and associated quality disciplines.

Qualifications

  • 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 is essential, along 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 facility, product design, development, production, distribution, installation, support, and service, as well as an understanding of quality management principles.
  • Exceptional oral and written communication skills are required. Personal attributes should include strong interpersonal skills, leadership qualities, maturity, decisiveness, self-reliance, and sound judgment.
  • Effective communication skills are crucial, with the ability to collaborate effectively across divisions and technical areas.
  • A minimum of 6 years in Quality Assurance, with some management experience preferred, and an additional 3 years in another function within the pharmaceutical or medical device industry. A total of at least 10 years of combined experience is expected.
  • ASQ certification is preferred.

Additional Information

This position is subject to applicable pay disclosure requirements under state or local law. The compensation range provided reflects the anticipated base pay for this role, which may vary based on factors such as geographic location. Individual compensation may differ from the posted range.

Allergan offers a comprehensive benefits package, including paid time off (vacation, holidays, sick leave), medical/dental/vision insurance, and a 401(k) plan for eligible employees. This position is also eligible for participation in short-term and long-term incentive programs.

Allergan is dedicated to operating with integrity, fostering innovation, transforming lives, serving our community, and embracing diversity and inclusion. We are committed to employing qualified individuals without discrimination based on race, color, religion, national origin, age, sex, physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected status.