Sr. Manager, Quality Assurance: Stable, Growing Generic/Specialty Pharma – Central NJ or Hartford, CT: RETAINED SEARCH

Cornerstone Search Gorup
Published
January 7, 2022
Location
Central, NJ or Stamford, CT Area, United States of America
Category
Job Code
lcrNH3097li
Contact Email
lcrodriguez@cornerstonesg.com

Description

Senior Manager – Quality Assurance: Stable, Growing Generic/Specialty Pharma – Central NJ or Hartford, CT area: RETAINED SEARCH

SUMMARY:  Cornerstone has been retained by a very stable and growing Generic/Specialty Pharma that is looking to hire a Sr. Manager – Quality Assurance to work along with the Head of Quality Assurance.  They operate in a nimble and creative work environment with an exceptional culture which is exemplified by the tenure of their employees (hiring manager has been with the company 10+ years).  While operating like a smaller company without the typical larger company obstacles, they are also extremely stable with a strong appetite for further growth. The Hiring Manager is a well-respected industry veteran and is well respected at the company and the industry. Our client’s work-life balance philosophy is built on trust and hard-work.  Since this is a hands-on role, you will be given a great deal of autonomy and flexibility.

POSITION:  Senior Manager – Quality Assurance

LOCATION:  Central NJ or Hartford, CT area office based (some flexibility available)

ATTRACTIVE FEATURES ABOUT THIS POSITION AND COMPANY:

  • Company Culture/Environment: The smaller company culture and autonomous environment offer an excellent opportunity for a hard-working individual to make a positive impact.
  • Visibility: A highly-visible role where you will interact with all levels of the organization.
  • Growth Potential: Our client is stable and expanding their product offerings beyond typical generics.

RESPONSIBILITIES:

  • Manage and supervise the company’s cGMP compliance assessment.
  • Lead and train team of associates and coordinators.
  • Perform, support and evaluate third party audits of current and proposed vendors for cGMP Compliance.
  • Manage the SOP system, including writing/ revising and maintaining SOPs, SOP Tracking and SOP Training.
  • Manage market distribution of batches.
  • Review and resolve batch deviations / Out-of-Specification (OOS) reports and proposed Corrective and Preventative Actions (CAPAs) from manufacturers.
  • Manage investigation and follow-up on product quality complaints.
  • Manage the QA review and internal market distribution procedure for ANDA drug product, OTC, Dietary Supplement and Medical Food products.
  • Support FDA audits/inspections of the company or its manufacturing partners, as needed.
  • Product Quality Reviews, including review of manufacturers' reports of annual product reviews.
  • Manage change control review.
  • Batch record reviews, as required.

REQUIREMENTS:

  • Minimum 10 years’ experience in the pharmaceutical industry with focus in Quality Assurance / Quality Systems.
  • QA-management role/managing a team experience preferred.
  • Bachelor’s degree required with a focus in science/biology/chemistry/technology preferred.
  • Experience of CFR 211 or CFR 210 preferred.

CORNERSTONE’S PRIVACY POLICY:

Cornerstone Search Group considers all inquiries, resume submissions, and any other personal information submitted/shared with us as confidential information.  Any information provided/shared with us will not be shared with any parties outside of Cornerstone Search Group without your prior permission.

CONTACT:

Lavinia C. Rodriguez | Director
E: lcrodriguez@cornerstonesg.com
P: 973.656.0220 x740
LinkedIn:linkedin.com/in/laviniacrodriguez/

CORNERSTONE SEARCH GROUP - Pharma & Biotech Executive Search

PO Box 5657 | Parsippany, New Jersey 07054 USA

www.cornerstonesg.com

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