Job Title: Product Quality Manager Location: Richmond, VA (Hybrid / Onsite 3 days Per Week) Job Type: Permanent Full-Time
We are searching for a permanent full-time Product Quality Manager (PQM) to join the Nasal Spray Products team of a global pharmaceutical company. The PQM is responsible for the planning, co-ordination, leading and managing the operational quality activities for nasal spray products through late- stage development to commercial launch.
As part of this role, the successful candidate will:
Work cross functionally in support of new product launches and technical transfer projects, including quality oversight of process validation and analytical method validation.
Actively monitor, review, and manage change controls, deviations, lab investigations and product complaints. Ensure compliance with the with the current Market Authorization or investigational regulatory filing.
Raise deviations as necessary and contribute to investigations, root cause analysis and CAPA identification on a case-to-case basis.
Manage the quality elements of the Supply Chain including the quality relationship with the third-party contactors.
Provide final oversite of formulation, manufacturing, packaging, testing and inspection records to ensure GMP completeness, accuracy, and legibility.
Represent the Quality function and perform quality tasks in support of development, scale-up, technical transfer, and commercial projects.
Maintain Inspection Readiness and support management during inspections by competent authorities. Ensure all regulatory audit findings are formally closed out.
Bachelor’s degree in a relevant scientific or engineering discipline.
10+ years of pharmaceutical, medical device, or drug-device combination product quality experience.
Direct experience in finished product dispositioning including review of manufacturing and packaging batch records as well as analytical/microbiological testing results.
Experience in Quality Control and/or Design Control is strongly preferred.
In depth knowledge of current US GMP (21 CFR Part 4, 210, 211, 820), and broad knowledge of international regulatory requirements and standards including: EU (Volume 4, Part 1), Health Canada, TGA, ISO 13485 and ICH (Q7, Q8, Q9, Q10).
** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.
SRG is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.