SRG, the leader in the Life Sciences human capital industry, is looking for a full-time contract Product Quality Lead to join our client's pharmaceutical manufacturing team in Raleigh, NC OR Richmond, VA.

*This position is hybrid onsite Tues- Thur.

*Likely contract extension or potential to become permanent.

MUST HAVES:

• Background in Quality Assurance
• Pharmaceutical Sterile Manufacturing - Must have worked in a sterile/aseptic manufacturing GMP facility with a strong understanding of the manufacturing process
• Batch record review for sterile products (vial or syringe filling - preferably syringe filling)
• Experience and knowledge of FDA and EU Guidelines and Annex 1
• Providing QA oversight to Contract Manufacturing Organizations / Contract Packaging Organizations / Third Party Logistics Providers
• Experience working with Supply Chain/Supply Planning and coordinating the release and shipment of batches
• Strong Deviations/Technical Writing skills
• Determined mindset and future vision for the company
• Familiar with using VEEVA and TrackWise, D2

JOB RESPONSIBILITIES:

• Quality leadership and compliance across multiple levels within the Supply Planning and Quality teams
• Contract Packaging management of all QA activities on product launches; pack changes and product release.
• Sterile Manufacturing management of Quality and Technical activities at CMO supporting the implementation of changes; updates; production and release of life-saving semi-finished drug product compliant with multiple regulatory guidelines in the US and across the world.
• Manage and lead complex activities in a multi-faceted team and organizations to launch products in new markets.
• Provide business support driving improved metrics leading CMO and CPO Joint Operation Teams monthly meetings with increased efficiency in manufacturing & packaging, demonstrated reduction of quality events and significant improvements on RFT across both manufacturing and packaging sites.
• Efficient and good communicator with demonstrated ability to work under severe pressure over multiple assignments.
  o Product Launches
  o New components implementation
  o Main Lead on Critical Quality Events with global impact
  o Direct FDA/EMA/TGA/Canada Health audit support

* 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.