SRG, the leader in the Life Sciences human capital industry, is looking for a full-time permanent Manager of Quality Operations located in Warren, NJ for a global Biotechnology company. This position is responsible for leading a team of quality specialists and ensuring that product production meets design specifications, quality system requirements, and GMP/FDA regulatory requirements. This is a hands-on manager role that is directly involved with day-to-day operations required to produce IVD products.

JOB RESPONSIBILITIES include, but are not limited to:

• Maintain quality system compliance with ISO 13485, QSR, IVDR, CMDR, MDSAP, and any other applicable global regulations.
• Oversight and coordination of the Change Control and CAPA (deviation, NCMR, OOS, CAPA) programs.
• Participate in the development, planning and implementation of reagents, assays, software and hardware life cycle management for automated instrumentation and qualification of new/revised test methods, equipment and product/process validation initiatives related to manufacturing.
• Overall responsibility for Quality Operations approval of Design Transfer activities from R&D to Manufacturing, inclusive of production and manufacturing process qualifications.
• Assist the Quality Management Representative in escorting and providing information to Regulatory officials during external audits. Support supplier and internal audits, as needed.
• Manage the new hire and ongoing training programs for quality-related subjects. Manage personnel attendance and perform employee appraisals and competency evaluations as required.
• Manage the QA review and approval of incoming material, labeling, line opening/closing, in-process and finished device history records, including BASIS release and ERP transactions

WHAT YOU NEED TO HAVE:

• Bachelors degree in a science related field (biology, chemistry, biomedical, etc)
• A minimum of five (5) years experience in IVD (in-vitro diagnostics), and/or pharmaceutical experience required
• Two(2) or more years experience in a quality management role, managing a team of 3 or more team members.
• Extensive knowledge of Quality System Regulations (QSR) and GMP
• Working knowledge of 21 CFR 820, ISO 13485, EU IVDR, CMDR
• Experience with an eQMS is preferred (i.e. TrackWise or MasterControl)

** 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.