Quality Assurance Manager – Pharmaceutical Supply Chain

Quality Assurance Manager – Pharmaceutical Supply Chain

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

Location: Durham, North Carolina, USA – WFH with site travel across US

Salary: $85,000k - $90,000k DOE; Full time permanent position

·        Work from Home position with regular travel to US sites (Florida, Durham NC, Boston and California)

·         We offer excellent full-time benefits including comprehensive; - Health insurance (options to buy-up to add spouse/family) Health Care plan) 401k contributions at 4% 15 PTO days per year paid holidays.

This is an excellent opportunity to join a global pharmaceuticals storage organisation in a USA Quality Assurance Manager appointment. You will be overseeing and coordinating all daily, weekly, and monthly quality / audit activities across the US sites ensuring full compliance with all regulatory, ISO, CAP and GxP standards.

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

Key Areas: -

• 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
• Documentation reviews and supplier qualification
• Clinical Sample / Tissue / Drug and Bio storage exp
• Maximising commercial opportunities

The key responsibilities: -

·        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.

Person Specification: -

- 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