Quality Manager

New Brunswick, New Jersey

Job Title: Quality Manager
 
Location: New Brunswick, NJ (Onsite)
 
Job Type: Contract
 
Duration: 12 Months
  
Responsibilities:  

  • 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 (SOP’s), authoring and executing Risk Mitigation Plans as needed
  • Determines disposition of drug products according to organization and regulatory specifications and standards
  • Review change requests generated internally or by External Manufacturer
  • Reviews Annual Product Quality Reviews (APQR’s) authored by Contract Manufacturers/Packagers and supplement APQR’s as required
  • Investigate and/or evaluate manufacturing, packaging and laboratory deviations or incidents and associated Corrective and Preventive Actions (CAPA’s) and provide direction and recommendations as to future course(s) of action
  • Review Quality Agreements
  • Review and 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 company’s standard and current Good Manufacturing Practices (cGMP)

 
Required Skills:  

  • Bachelor’s degree required in Natural Sciences, Chemistry, Microbiology, Biology, Engineering, Pharmacy.
  • Five years pharmaceutical experience with batch record review, deviation and change control oversight experience
  • 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

 
About SSi People: 
With over 25 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well. 
 

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