Collegium Pharmaceutical

Senior Quality Assurance Manager

Job Locations US-MA-Stoughton
Posted Date 5 months ago(5/10/2022 12:58 PM)
ID
2022-1527
Category
Regulatory Affairs & Quality Assurance

Overview

At Collegium Pharmaceutical, we are building a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions. We have a portfolio of meaningfully differentiated medications to treat serious medical conditions, including moderate-to-severe pain and acute migraine.

 

As Collegium’s Senior Manager of  Quality Assurance, you will be instrumental in the management and evolution of the Supplier Quality Program to meet the challenges of commercial drug product supply. The Senior Manager will be responsible for the GxP supplier management program which oversees contract manufacturing organizations, testing laboratories and material/service providers. This role will act as interdepartmental liaison to various groups including Manufacturing, Supply Chain, Quality Control and Regulatory Affairs. They will ensure compliance with all aspects of 21CFR §210, §211, and §820 cGMP. 

 

Persons applying for employment with Collegium Pharmaceutical on and after August 1, 2021, who are offered a position are expected to be able to provide proof of vaccination against COVID-19 prior to their start date as permitted under state law, unless they seek and are approved for an exemption by Collegium as a reasonable accommodation based on bona fide religious or medical grounds.

 

Responsibilities

  • Manage the execution of supplier audits; ensure audit response and follow-up.  Manage the approved supplier list, the yearly audit schedule, and ensure completeness and accuracy of vendor files.
  • Collaborate with external and internal stakeholders to ensure supplier partnerships and contractual commitments are well understood and executed appropriately.
  • Develop and implement supplier performance scorecards, and present supplier quality metrics for routine updates to Management teams.
  • Manage the Annual Product Reviews program for Collegium’s commercial portfolio.
  • Manage the development and maintenance of Quality Agreements with suppliers.
  • Assist in the development and implementation of GxP quality standards, policies, and procedures.
  • Represent the Quality organization to internal and external stakeholders.
  • Inform Quality management of issues and progress of assigned projects.
  • Assist with FDA inspections, other regulatory inspections, and audits.
  • Support the Clinical Operations Vendor management program.
  • Manage the department budget for contractors and consultants hired to perform audits.

Qualifications

  • Bachelor’s degree in in science or related field
  • 6-10 years of experience working in a Good Manufacturing Practices (GMP) environment (specifically Pharmaceutical or Life Sciences) with knowledge of QC testing, sampling, labeling, and release required, minimum of 4-6 years of Quality Assurance experience in pharmaceuticals or biologics.
  • Demonstrated experience interpreting and implementing cGMPs.
  • Experience in pharmaceutical Quality Assurance management including the ability to identify and resolve compliance issues, make independent decisions, demonstrate good judgment in escalating issues, and drive change in quality programs throughout the organization required
  • Experience in implementation and administration of quality systems for drug development, manufacturing, and quality control operations.
  • GCP experience and/or controlled substance experience a plus
  • Strong verbal and written communications skills.

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