Job Summary
Reporting to QA Head of US & APAC, the US GMP compliance head will play a pivotal role in ensuring the highest standards of professional excellence, regulatory adherence and quality within the business, with overall responsibility and accountability of cGMP compliance across US sites. Working closely with each US site quality head in all areas of the business, this position will play an integral role in the development of US QMS strategy/business planning in US, aligned closely with the global QA function. In addition to this core responsibility this role will also act as key person for leading each US site to prepare for regulatory onsite inspection, including FDA and EMA.
Job Responsibilities
- Key member of QA leadership team for WuXi Biologics US sites. The incumbent will 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.
- S/he will be 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 market, 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 is required by site management & global QA.
Technical Competencies
- It is desirable s/he has extensive knowledge of legislative, regulatory, market, biologics and data integrity requirements.
- S/he must acknowledge current WuXi quality system and have 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.
Knowledge
- Strong level of knowledge of FDA, EU, international and legislative requirements
- Demonstrated experience within highly regulated environment, including FDA, EMA
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.
Behavioural Competencies
- Strong communication skills with demonstrated ability to work in a matrix environment.
- Excellent leadership skills
- Strong analytical skills
- Strong decision maker based on risk level is a key competency of this role.
- Result and solution focused
- Strategic thinker with drive for business continuous improvement and customer focused
