Degree in Biopharmaceutical Science or related field required; equivalent qualifications with experience considered.
Strong background in bio-pharma or pharma/science, with preferred CDMO experience.
Extensive knowledge of regulatory requirements for FDA, EU, and international standards.
Experience managing teams across multiple sites during startup and sustaining phases.
Strong analytical and decision-making skills focused on risk assessment.
Responsibilities
Lead compliance across US sites, ensuring adherence to cGMP standards and regulations.
Establish quality systems at new US sites in collaboration with site QA heads.
Manage GMP compliance team and oversee self-inspection programs for regulatory compliance.
Participate in global QMS projects and ensure alignment with regulatory expectations.
Collaborate closely with US site quality heads to support GMP activities.
Prepare US sites for regulatory inspections, including FDA and EMA.
Fulfill additional duties as required by site management and global QA.
Benefits
Comprehensive health insurance coverage.
Professional development opportunities.
Collaborative work environment with a focus on quality and compliance.
Participation in global QMS initiatives.
Opportunities for leadership development in a rapidly growing company.
Full Job Description
Job Title - US GMP Compliance Head
Department - Quality Assurance
Work Location - Cranbury NJ (On-site)
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
The salary range for this position is $160,000 - $260,000
Job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.
