Senior Quality Assurance Manager, Auditing
Join an organization united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, you are the most valuable asset. My client has been operating in the biotech sector for 25 years, with a proven track record of resiliency in the face of adversity. The success of the company's lead product has already provided a significant commercial foundation, allowing them to reinvigorate their research efforts, and grow their team in the areas of Drug Discovery, Clinical Development, Commercial, and more! As they expand their global partnerships and further reinvest in R&D to discover the next breakthroughs for difficult-to-treat cancers, they're seeking to add talented, dedicated employees to power their mission.
The Senior Quality Assurance Audit Manager is responsible for leading and conducting GxP external audits with a focus on GMP vendors to assure compliance with the Internal Audit Program. Assesses vendor processes, systems, and procedures to evaluate their quality performance against established standards and regulatory requirements. The Senior Quality Assurance Audit Manager supports the Vendor Management framework by providing audit results to identify and manage risks and escalate issues in a timely fashion. Conducts internal audits to drive continuous improvement activities across the organization. This position contributes to the success of clinical and commercial products in driving quality through vendor performance qualification and monitoring.
- Independently plans, performs, and reports on GxP external and internal audits, including follow-up activities.
- Assesses quality and compliance risks in the field and escalates potential high-risk issues to Management.
- Supports development, tracking and managing periodic management reports including key QA metrics related to the Audit Program.
- Reviews and approves Corrective and Preventive Actions (CAPAs); ensures audit findings are closed on time.
- Liaises between vendors and internal stakeholders to support GxP compliance and business needs to facilitate risk-based approach and analysis of audit results.
- Maintains knowledge of current regulatory requirements and guidance and advises stakeholders and management of potential impact on the organization.
- Supports and participates in audits, both internal and external.
- Participates in identifying and implementing process and system improvements.
- Evaluates and generates data to support departmental metrics.
- Bachelor's degree in related science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering) and eight plus years of related experience; or
- Master's degree in related science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering) and six plus years of related experience; or
- PhD in related science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering) and three plus years of related experience; or
- Equivalent combination of education and experience.
Knowledge & Skills
- Proven knowledge and experience in GxP quality auditing.
- Demonstrated GxP quality auditing experience with a focus on GMP processes.
- Auditor certification is recommended, but not required.
- Demonstrated knowledge of the drug development process.
- Has a strong understanding of relevant regulatory and audit frameworks that apply to biopharmaceutical operations and working knowledge of international Health Authority regulations and guidance.
- Excellent organization skills for audit preparation, execution, and closure.
- Ability to influence others as part of a collaborative team and negotiate effective solutions.
- Strong interpersonal and social skills.
- Has a broad expertise or unique knowledge and skills to contribute to development of company objectives and principles, and to achieve goals in creative and effective ways.
- Interprets regulatory standards, provides insight into current processes, and recommends modifications to applicable procedures.
- Detail oriented and committed to precision in execution of tasks and processes.
- Excellent verbal and written communication skills and presentation skills. Make clear recommendations and communicate effectively.
- Proficient in MS Office.
- Environment: primarily working indoors, performing clerical work.
- Ability to travel approximately 40% (and perform desk-based virtual audits prior to lifting of COVID-related travel restrictions).