US GMP Compliance Head

Job Responsibilities

• Key member of QA leadership team for WuXi Biologics US sites.
• Play an integral role in the strategy and business planning processes, ensuring sites collaboration and leadership execution for WuXi Quality Management System, inclusive of GMP standards, compliance programmes.
• A key element of the role as supporting new US site startup, include establishment of WuXi Biologics quality system together with site QA head and associated leadership cascade across all functional areas.
• Responsible for managing a GMP compliance team and be involved in US sites self-inspection program to audit each site, to assure each site GMP operation in compliance with all regulatory markets, EU, FDA and company standards.
• This role will also participate in global QMS projects and ensure global implementation and delivery aligned with regulatory and client expectations.
• Supporting all areas of the business, this function will work very closely with each US site quality head to support all GMP activities.
• Act as US regional QA head with responsibility of leading each US site to prepare for regulatory onsite inspection, including FDA and EMA.
• Other activities which are required by site management & global QA.

Technical Competencies

• Extensive knowledge of legislative, regulatory, market, biologics and data integrity requirements.
• Working experience to set up local QMS based on corporate QMS.
• Design and deployment of integrated Quality Management Systems, digital platforms, and data governance frameworks ensuring compliance, traceability, and audit-ready documentation.

Experience

• Strong demonstrated experience working in bio-pharma or similar experience in a pharma/science background, and have CDMO working experience is preferable.
• Demonstrated experience leading a team across multiple US sites in startup and in sustaining phase a key desirable for this role.

Qualifications

• To support the scope of responsibility and level of accountability ideally the candidate should be qualified to degree level in Biopharmaceutical Science or other related science discipline.
• Equivlanet qualification with demonstrated experience will be considered.

Salary Range

The salary range for this position is $160,000 - $260,000.

Equal Opportunity Employer

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.