SRG, the leader in the Life Sciences human capital industry, is looking for a full-time, permanent Product Quality Manager - Oral Solid Dose/Nasal Spray to join our client's manufacturing team in Raleigh, NC or Richmond, Va. This role is responsible to plan, co-ordinate, lead and manage the activities of the Operational Quality Section to ensure that all the relevant process raw materials, intermediates and final products are manufactured, packaged, tested, and dispositioned in full compliance with cGMP and regulatory requirements.

*Onsite hybrid, Tues-Thur. *THIS POSITION CAN BE BASED IN RALEIGH OR RICHMOND.

Must Haves:

• 8-15 years of quality experience, in the FDA/GMP pharmaceutical industry
• Direct experience in finished product dispositioning
• Required experience with injectable manufacturing (can be syringes, vials, or containers; sterile is not required)
• Expert in EU Regulations
• Proven track record as a leader in full cycle product management and overseeing a team
• Direct experience in reviewing manufacturing and packaging batch records as well as analytical testing results
• Microbiological experience, a plus

Responsibilities:

• Ensures that release documentation provided by third party suppliers complies with all required and Regulatory standards.
• Provides final INDV oversite of formulation, manufacturing, packaging, and inspection records to ensure GMP completeness, accuracy, and legibility.
• Provides batch disposition of commercial product(s) manufactured in the US and ready for disposition into all authorized markets.
• Manages the quality elements of the Supply Chain for the commercial products manufactured in the US. This includes managing the quality relationship with the third-party contactors.
• Works with Supply personnel to foster dynamic working relationships with pre- wholesalers / wholesalers in North America to ensure continuity of patient supply of products within label requirements.
• Maintains Inspection Readiness of the Product program and supports management during inspections by competent authorities. Ensures all regulatory audit findings are formally closed out.
• Participates in internal audits and remediates any issues to agreed timelines.
• Executes external audits of North American suppliers per the approved audit schedule, as required. Follow up and complete and CAPAs required.
• Actively monitors and manages change controls, deviations, customer complaints and has quality oversight/approval to ensure compliance with the current Market Authorizations.

* Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.