The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.
A Pharmaceutical Company is seeking a Quality Manager in Princeton, NJ.
• Manages CMO relationships from a quality and compliance perspective, including monitoring quality metrics, performing annual risk assessment of CMOs and executing oversight as defined by standard operating procedures (SOPs), authoring and executing Risk Mitigation Plans as needed
• Determines disposition of drug products according to company's and regulatory specifications and standards
• Review/ Approve change requests generated internally or by External Manufacturer
• Reviews Annual Product Quality Reviews (APQRs) authored by Contract Manufacturers /Packagers and supplement APQR as required
• Investigate and/or evaluate manufacturing, packaging and laboratory deviations or incidents and associated Corrective Actions and/or Preventive Actions (CAPAs). Provide direction and recommendations as to future course(s) of action
• Review and approve Quality Agreements as required
• Approve product quality complaint investigations
• Review and approve validation/qualification protocols and reports from the External Manufacturer as defined in related Quality Agreements
• Write, review and implement SOPs to ensure compliance with current ourstandard and current Good Manufacturing Practices (cGMP)
• Serve on Fact Finding Investigation Team (FIT) and Fact Finding Investigation Review Meetings (FIRM)
• Supports product recalls and executes plan as assigned
• Assist with preparation of audit observations
• Participate in audits (For Cause) of North American External Manufacturers of drug products ensuring compliance with all appropriate and FDA and European Medicines Agency (EMA) agency cGMP regulations and policies
• Represent Quality on cross-functional teams within the "Virtual Manufacturing Plant", Technical Transfer teams, Supplier Selection, Serialization, Manufacturing, Packaging launch teams
Skills & Requirements
• B.S. in Natural Sciences, Chemistry, Microbiology, Biology, Engineering, Pharmacy or equivalent
• A minimum of 7 years’ experience in pharmaceutical, biologics, biotech or related industry with relevant experience
• Experience in a Quality Assurance, Quality Control or equivalent function is required
• Experience in the manufacture of drug substance and/or drug product or quality control laboratories is desired
• Knowledge in solid dosage forms, parenteral technology, biologics or combination products
• Knowledge of compendial and cGMP requirements, FDA regulations and the ability to interpret and apply them
• Proficiency with the use of global systems (e.g., Systems, Applications and Products (SAP), Document Control and Archiving (DCA))
• Good verbal and written communication skills essential
• Excellent interpersonal skills
• Capable to manage multiple priorities
• Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirement are met
• Trained in auditing techniques and skills such as observation, questioning, and assessment of complex problems
You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.
Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.
• Life Insurance ($20,000 benefit)
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Hays is an Equal Opportunity Employer including disability/veteran.
In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570
Drug testing may be required; please contact a recruiter for more information. #1142178