Collegium Pharmaceutical

Quality Assurance Manager

Job Locations US-MA-Stoughton
Posted Date 2 weeks ago(1/5/2022 9:26 AM)
ID
2022-1488
# of Openings
1
Category
Regulatory Affairs & Quality Assurance

Overview

Collegium Pharmaceutical is committed to becoming the leader in responsible pain management. Our portfolio compels us to step into the pain market at a time when others have opted to step out. We recognize the importance of earning the trust of key stakeholders every day. We will continue to work hard to position Collegium to usher in a next generation of non-opioid pain solutions in the US market. We remain focused on making a positive difference in the lives of people suffering from pain and our communities.

 

 

POSITION OVERVIEW

 

The Manager, Quality Assurance will be responsible for supporting the manufacturing, testing, and release of drug products for clinical and commercial use. They will ensure compliance with all aspects of 21CFR §210, §211, and §820 cGMP.  This role will be responsible for providing leadership in the management of critical quality systems (i.e. : Change Control, Training, Deviations, CAPAs, Stability, Calibration and Preventive Maintenance, etc )that allow the company to maintain all licenses to operate.  This individual will be critical in supporting interdepartmental and cross functional project management activities.

 

Responsibilities

  • Develop, review, and approve company documentation including Standard Operating Procedures (SOPs), Analytical Test Methods, Product Specifications, Change Controls, Validation Protocols, Validation Reports, and Master Batch Records
  • Liaise with vendors’ (Contract Manufacturing Organizations (CMOs), Contract Testing Laboratories, etc.)  Quality Assurance departments
  • Review and approve or reject bulk drug product, and packaged/labeled products per established specifications and determine final disposition of clinical and commercial manufactured products
  • 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.
  • Manage controlled substances inventory and destruction
  • Perform Annual Product Reviews.
  • Assist with development and maintenance of Quality Agreements with suppliers.
  • Assist with FDA inspections, other regulatory inspections and audits.

 

Qualifications

  • BS degree in Pharmaceutical or Life Science with a minimum of 4-6 years of QA experience in pharmaceuticals or biologics.
  • Demonstrated knowledge of 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.
  • Strong verbal and written communications skills.
  • GCP experience and/or controlled substance experience a plus

 

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