Quality Assurance Manager
Proclinical is currently recruiting for a Quality Assurance Manager with a pharmaceutical company located in Boston, MA.
- Responsible for product quality performance through product and supplier Quality Risk Management, deviation/investigation review, change management, APQR evaluation, and supplier auditing.
- Supports and champions implementation of compliance strategies, quality plans and Commercial Quality Assurance programs for the management of material procurement, product manufacturing/packaging operations to assure quality and compliance
- Establish quality and compliance expectations for CMOs and CTLs; performing strategic systems reviews and coordinate risk/benefit analyses of supplier processes and systems to assure compliance with cGMP's.
- As necessary works with specific company LOCs to assure compliance with country-specific requirements/regulations for the packaging of product for represented markets
- Works with ESQL team to support and/or lead audits of CMOs or CTLs, including development or audit reports and review of the acceptability of CMO/CTL corrective actions.
- Provide oversight in the assessment of changes or deviations for company products, to assure compliance to regulatory commitments, assessment and evaluation of risks, appropriate disposition of product, and correction or improvement of operations to minimize future risks.
- Maintains awareness of relevant legislation and regulatory guidelines and assures that QA supplier management programs, systems and controls are reviewed and updated as needed to assure compliance. As necessary, confirms requirements and regulations of other company markets in support of manufacturing, testing and packaging activities.
- Ensure successful and timely completion of all product submissions, launches and new company initiatives within company, as well as at our contract manufacturing, packaging and labeling operations.
- Assist with regulatory inspections of Oncology, Small Molecule
- Identifies key trends and emerging issues at suppliers and implements corrective actions as needed.
Skills and Requirements:
- Bachelor's Degree in Pharmacy, Chemistry, Biology or related discipline and minimum of 8 years of QA/QC experience in the pharmaceutical industry and/or QA/QC laboratory environment.
- Experience of cGMPs, ICH and other pertinent regulations
If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.