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Quality Manager

  • Location: New Brunswick
  • Job Type:Contract

Posted about 1 month ago

  • Expiry Date: 26 September 2022
  • Referral: 215193@accuick.com

Job Description:

  • 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 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 standard 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

  • Represent during FDA/other regulatory inspections and corporate Good Manufacturing Practices (GMP) compliance audits as defined in related Quality Agreements

  • 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

Qualifications:

  • 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

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.

Full Name: Akash Mehra

Email IDakashm@askconsulting.com

Phone: 908-224-9613