Sr. Manager Quality Audit and Compliance

Princeton, NJ - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Please note that this position can be based in San Diego CA OR Princeton NJ OR San Francisco CA. Acadias hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Senior Manager Quality Audits is responsible for leading and executing internal and external audits across Acadias expanding portfolio. This role plays a critical part in ensuring compliance with GMP and GxP regulations maintaining robust Quality Agreements and supporting the ongoing effectiveness and continuous improvement of Acadias Quality Management System. The position serves as a subject matter expert for audit readiness regulatory compliance and quality system optimization across clinical and commercial operations.

Primary Responsibilities

Plan coordinate schedule and conduct internal and external GMP/GxP compliance audits ensuring CSPs meet Acadia standards and all applicable FDA EU (EudraLex) Canadian and international regulatory requirements
Prepare review issue and track audit reports and observations to closure; compile analyze and present audit metrics and trends to support management review
Develop review negotiate and maintain quality agreements with clinical and commercial CSPs
Maintain and continuously improve the internal audit program including coordination of GxP audit activities with internal and external stakeholders
Prepare review format and maintain SOPs and recommend or implement policy and procedural changes that may impact departmental or company-wide operations
Provide GMP compliance expertise and advisory support including support for annual product reviews mock recalls field alerts and actual recall events
Support the selection implementation validation and continuous improvement of quality systemrelated computerized systems including CSV support as needed
Lead and support continuous improvement initiatives aligned with GMP and industry best practices while ensuring compliance with company policies including Privacy/HIPAA and other legal requirements
Other duties as assigned

Education and Experience

Bachelors degree in a Life Sciences or related field. An equivalent combination of education and applicable job experience may be considered.
Targeting 6 years of progressively responsible experience within quality assurance (QA) including 3 years directly responsible for GMP QA with knowledge of external and internal auditing.
Extensive knowledge of guidelines and international regulations that affect the GMP QA programs.
American Society for Quality (ASQ) or ECA academy certification and/or European Lead Auditor experience is a plus.

Key Skills:

In-depth understanding of quality management best practices within the pharmaceutical or biopharmaceutical industry
Demonstrated expertise in QA activities and GMP regulations (FDA EU ICH) across clinical development manufacturing technology transfer and commercial operations
Strong ability to interpret and apply U.S. and international cGMP requirements
Proven experience conducting internal audits supplier audits and manufacturing site inspections
Ability to translate quality standards into practical implementation and review activities
Clear effective communicator with experience presenting technical and compliance-related information to cross-functional audiences
Strong collaboration skills with the ability to influence and gain cooperation across functions
Willingness to travel domestically and internationally (approximately 2530%)

Scope

Manages department section to achieve goals in accordance with established policies and to meet schedules and/or resolve problems. Follows processes and operational policies in selecting methods and techniques for obtaining solutions; determines how to use resources to meet schedules and goals. It will require a focus on issues of moderate to diverse scope which will require evaluation of a variety of factors and an understanding of functional area objectives and trends. Erroneous decisions or failure to achieve results may add to costs and impact the short-term goals of the organization.

Physical Requirements

This role involves regular standing walking sitting and the use of hands for handling or operating equipment. The employee may also need to reach climb balance stoop kneel crouch and maintain visual verbal and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-Hybrid #LI-SL1

Required Experience:

Manager

Please note that this position can be based in San Diego CA OR Princeton NJ OR San Francisco CA. Acadias hybrid model requires this role to work in our office three days per week on average.Position SummaryThe Senior Manager Quality Audits is responsible for leading and executing internal and extern...