US Pharmaceutical Quality Assurance Manager

Sector:
Pharmaceutical & Life Sciences Supply Chain, Clinical Sample storage, testing, Drugs, Lab,

Location:

Durham, North Carolina, USA – WFH with site travel across US / East Coast

We offer comprehensive benefits:

- Health insurance (options to buy-up to add spouse/family) Health Care plan) 401k contributions at 4% + 15 PTO days per year paid holidays.

Reporting to the Head of Global Quality you will be the main point of contact for USA Global Pharmaceutical customers, biomanufacturing, biologics distribution and cold storage site operations teams supporting with all quality assurance and compliance audit standards.

Degree / Major in Quality, Pharmaceuticals, Biology, Chemistry, life sciences or related engineering subjects

• Pharmaceutical Quality Assurance
• USA compliance regulatory, ISO, CAP and GxP exp
• Day to day audit management of the Pharma / Life Science / Storage processes
• Pharmaceutical and biomanufacturing experience
• cGMP / GMP experience
• Pharmaceutical manufacturing, OCM, Labs / R&D, Sample / Tissue / Drug storage exp

• Lead and drive Quality objectives across all US sites, ensuring adherence to company procedures & policies, safety standards, and regulatory frameworks (ISO 9001, CAP, ICH Q1A/Q1B, cGMP as applicable).
• Serve as the US QA Manager, overseeing regulatory compliance, e-QMS execution, and site-level governance across all US sites.
• Collaborate closely with Head of Quality ensuring efficient streamlining as agreed in objectives and targets.
• Harmonise Global quality policies and procedures ensuring adherence on all US sites inclusive of SOP's, training, and audit programmes across the US.
• Oversee the planning and scheduling of internal and external audits, working closely with Head of Quality and Operational site leads where required.
• Conduct internal audits across all sites in line with the internal audit schedule, ensuring effective reporting and trending of findings.
• Ensure all relevant staff are trained and competent assigned e-QMS tasks where required.
• Implement process improvements.
• Leverage technical knowledge to mentor team members and contribute to continuous improvement initiatives across the e-QMS and wider business operations.
• Review and ensure all CAPA/incident related events are completed on time in full, including detailed investigations, root cause analysis, inclusive of supporting evidence, and timely closure as agreed and defined by the Head of Quality.
• Conduct routine site visits (all US sites) to verify process adherence, data accuracy, and compliance to Local and Global quality policies and procedures.
• Support operational teams with day-to-day QA queries, decisions, and risk assessments, highlighting significant issues to the Head of Quality.

• Previous experience of working within Pharmaceutical Storage supply chain environment
• Previous experience of life sciences multi customer lab quality operations
• Degree / Major in Quality, Pharmaceuticals, Biology, Chemistry, life sciences or related engineering subjects