QA Manager, Compliance (Biopharmaceutical)

Accepting BioReady™: Yes
Category: Quality Control / Assurance
Education: Master
Experience: 4-6 Years
Salary:
Location: Mississauga, ON
Posted: October 9, 2019
Closes: November 9, 2019

Job description:

The Quality Compliance Manager will be responsible for supervision of the Quality Compliance team, internal/client audits, supplier qualifications, SOP/WIN/DOC document control, Change Control, CAPA Closure /Effectiveness, APR, Quality Metrics for cGMP compliance in line with US FDA, Health Canada and EU requirements.

WHAT YOU WILL BE RESPONSIBLE FOR / PRIMARY ACTIVITIES:

  • Responsible for supervision of Quality Compliance team
  • Escalate compliance concern to senior management in a timely manner
  • Negotiate Quality Agreements with customers and suppliers, as required
  • Prepare Quality Agreement requirements easy reference sheet and keep it current for reference by other departments
  • Prepare annual schedule and conduct Internal Audits as per schedule
  • Prepare Internal Audit reports, negotiated departmental CAPA, and conduct CAPA effectiveness checks
  • Prepare and/or review responses for Health Authority, Regulatory and customer audits
  • Prepare annual schedule and conduct Supplier Audit as per schedule
  • Approve Complaints and Annual Product Reviews
  • Approve SOPs – Quality Operations, Manufacturing and Facilities
  • Administer Change Control program and Document Management requirements
  • Review and approve Pre and Post implementation major and emergency change controls
  • Review and approve CAPA for deviation, OOS, EM and audits
  • Maintain CAPA databases and prepare trend reports
  • Follow-up on CAPA completion for deviation, OOS, EM and audits for completion
  • Review and approve Validation and Qualification Protocols and reports including Analytical method transfers and validation
  • Approve Stability Protocols and Reports
  • Administer Training compliance
  • Approve Training Curriculums
  • Perform plant wide annual GMP training
  • Prepare and review trending of compliance systems for Quality Matrix Review
  • Review critical and major deviations reports and assess root cause and CAPA to QMS
  • Act as back-up for Senior Director, Quality Compliance
  • Assist with preparation of departmental budget, monitor and control spending
  • Allocate day to day work and monitoring completion of tasks of compliance team
  • Delegate responsibilities, coach and motivate staff, recruit and train new staff, monitor performance and progress of staff projects
  • Performs any other related duties as assigned

OUR MINIMUM REQUIREMENTS:

  • Graduate degree in a related science
  • 5-10 years of progressive QA experience in biopharmaceutical / Pharmaceutical industry
  • Minimum three years’ experience in supervisory role in Quality Assurance/Compliance in Pharmaceutical/ Biopharmaceutical Industry
  • Technical background and understanding of analytical methods
  • Demonstrated leadership and management abilities
  • Computer literacy
  • Training and experience in Microbiology will be an asset

ADDITIONAL REQUIREMENTS:

  • Pre-employment medical and medical re-examination performed every 2 years will be required as per Therapure’s SOPs.

While we appreciate your interest in this opportunity, only qualified candidates will be contacted.

Therapure Biopharma Inc. will not be responsible for any agency referral fees arising from the use of resumes that currently exist in the recruitment database or have been forwarded to Therapure Biopharma directly or indirectly without an authorized agreement. Agency referrals will not be accepted unless approved by the Therapure Biopharma Inc. Human Resources team.

NOTE:All employment is conditional upon the completing and obtaining a satisfactory background check, including pre-employment medical (where applicable), educational, employment, references, and criminal records checks (for which a pardon has not been granted).

Therapure is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process. Applicants are asked to make their needs/requirements known to Human Resources.

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