Senior Manager – Quality Assurance: Stable, Growing Generic/Specialty Pharma – Central NJ or Hartford, CT area: RETAINED SEARCH
SUMMARY: Cornerstone has been retained by a very stable and growing Generic/Specialty Pharma that is looking to hire a Sr. Manager – Quality Assurance to work along with the Head of Quality Assurance. They operate in a nimble and creative work environment with an exceptional culture which is exemplified by the tenure of their employees (hiring manager has been with the company 10+ years). While operating like a smaller company without the typical larger company obstacles, they are also extremely stable with a strong appetite for further growth. The Hiring Manager is a well-respected industry veteran and is well respected at the company and the industry. Our client’s work-life balance philosophy is built on trust and hard-work. Since this is a hands-on role, you will be given a great deal of autonomy and flexibility.
POSITION: Senior Manager – Quality Assurance
LOCATION: Central NJ or Hartford, CT area office based (some flexibility available)
ATTRACTIVE FEATURES ABOUT THIS POSITION AND COMPANY:
- Company Culture/Environment: The smaller company culture and autonomous environment offer an excellent opportunity for a hard-working individual to make a positive impact.
- Visibility: A highly-visible role where you will interact with all levels of the organization.
- Growth Potential: Our client is stable and expanding their product offerings beyond typical generics.
- Manage and supervise the company’s cGMP compliance assessment.
- Lead and train team of associates and coordinators.
- Perform, support and evaluate third party audits of current and proposed vendors for cGMP Compliance.
- Manage the SOP system, including writing/ revising and maintaining SOPs, SOP Tracking and SOP Training.
- Manage market distribution of batches.
- Review and resolve batch deviations / Out-of-Specification (OOS) reports and proposed Corrective and Preventative Actions (CAPAs) from manufacturers.
- Manage investigation and follow-up on product quality complaints.
- Manage the QA review and internal market distribution procedure for ANDA drug product, OTC, Dietary Supplement and Medical Food products.
- Support FDA audits/inspections of the company or its manufacturing partners, as needed.
- Product Quality Reviews, including review of manufacturers' reports of annual product reviews.
- Manage change control review.
- Batch record reviews, as required.
- Minimum 10 years’ experience in the pharmaceutical industry with focus in Quality Assurance / Quality Systems.
- QA-management role/managing a team experience preferred.
- Bachelor’s degree required with a focus in science/biology/chemistry/technology preferred.
- Experience of CFR 211 or CFR 210 preferred.
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CORNERSTONE SEARCH GROUP - Pharma & Biotech Executive Search
PO Box 5657 | Parsippany, New Jersey 07054 USA