Job Description

Quality Manager
Job Number: 21-10369
 
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Quality Manager for our client in New Brunswick, NJ.

 
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!

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 Client 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 SOP's to ensure compliance with current Client standard and current Good Manufacturing Practices (cGMP)
  • Participate as required on Fact Finding Investigation Team (FIT and Fact Finding Investigation Review Meetings (FIRM)
  • Supports product recalls and executes plan as assigned
  • Represent Client during FDA/other regulatory inspections and corporate 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 Client and FDA and European Medicines Agency (EMA) cGMP regulations and policies
  • Represent Quality on cross-functional teams within the "Virtual Manufacturing Plant", Technical Transfer teams, Supplier Selection, Serialization Manufacturing and Packaging launch teams
Required Qualifications:
  • 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
  • B.S. in Natural Sciences, Chemistry, Microbiology, Biology, Engineering, Pharmacy or equivalent
  • A minimum of five (5) 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
 

If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro 


If interested, you may contact:
Jay Lucas
arjay.lucas@eclaro.com
6463571240
Jay Lucas | LinkedIn
 
 

Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

 
 

Application Instructions

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