Collegium Pharmaceuticals

Quality Assurance Manager

US-MA-Canton
1 month ago(12/10/2017 4:20 PM)
ID
2017-1209
# of Openings
1
Category
Analytical Development & QC

Overview

The Company:

Collegium is a specialty pharmaceutical company focused on building a portfolio of pain-management products that incorporate its patent protected DETERx™ formulation platform that provides for sustained release and tamper resistance, as well as building a portfolio of in-licensed pain management products. Visit the Company’s website at www.collegiumpharma.com

 

Position Description: Collegium is seeking a qualified, highly motivated, experienced individual for the position of Quality Assurance Manager reporting into the Director, Quality Assurance.  This individual will be responsible for supporting the manufacturing, testing, and release of drug products for clinical and commercial use, as well as provide leadership in the management of critical quality systems that allow the company to maintain all licenses to operate.

Responsibilities

The Quality Assurance Manager is responsible for the following:

  • Assure compliance with all aspects of 21CFR §210, §211, and §820 cGMP.  Work diligently with peers to ensure processes are implemented, followed, and improved per applicable and current regulations.
  • Develop, review and approve company documentation including Standard Operating Procedures, Analytical Test Methods, Product Specifications, Change Controls, Validation Protocols, Validation Reports, and Master Batch Records. 
  • Liaison with Vendor (Contract Manufacturing Organizations, Contract Testing Laboratories, etc.…) Quality Assurance departments.
  • Review and approval or rejection of bulk drug product, and packaged/labeled products per established specifications.  Determine final disposition of clinical and commercial manufactured products.
  • Assist with management of the stability program as needed.
  • Assist with management of the calibration and preventive maintenance program for in-house GMP testing laboratory.
  • Represent the Quality organization to internal and external stakeholders.
  • Inform Quality management of issues and progress of assigned projects.
  • Perform internal audits and external audits of contract labs, CMOs and/or CROs.
  • Support controlled substances inventory and destruction.
  • Strongly support management of quality systems including: Change Control, Training, Deviations, CAPAs, etc…
  • Support interdepartmental and cross functional project management activities.
  • Support Annual Product Reviews.
  • Assist with development and maintenance of Quality Agreements with suppliers.
  • Assist with FDA inspections, other regulatory inspections and audits .

Qualifications

  • BS or MS degree in Pharmaceutical or Life Science with a minimum of 6-10 years of QA experience in pharmaceuticals or biologics.
  • Demonstrated knowledge of cGMPs.
  • Experience in pharmaceutical Quality Assurance including the ability to identify and resolve compliance issues.
  • Experience as an independent decision maker in a pharmaceutical or biotech setting, but demonstrates good judgment in escalating issues to management and QA colleagues.
  • Strong verbal and written communications skills.
  • Experience in implementation and administration of quality systems for drug development, manufacturing and quality control operations.
  • Can provide leadership to peers, and drive change in quality programs throughout the organization.
  • GCP experience a plus.
  • Controlled substance experience a plus.

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