Control lead

Change Control Lead – Quality Operations
Location: Toronto, Canada
Work mode: On‑site

We are seeking an experienced Change Control Lead – Quality Operations to support a regulated manufacturing site in Toronto. This is a highly visible, on‑site role focused on leading change control activities end‑to‑end, partnering with cross‑functional teams, and ensuring compliant, timely, and high‑quality execution within a GMP environment.

• Own and drive the full change control lifecycle from initiation to closure, including scope definition, impact and risk assessments, action planning, implementation oversight, effectiveness checks, and closure.
• Ensure appropriate routing and approvals across Quality, Engineering, Manufacturing, Supply Chain, IT, Validation, and other relevant functions.
• Author, review, and improve high‑quality change records with clear rationale, justification, and traceability.
• Triage and prioritize incoming change requests; support stakeholders in defining implementable and compliant changes.
• Maintain trackers, manage backlogs, expedite risks or delays, and propose recovery plans.
• Facilitate and document quality risk assessments (e.g., FMEA or equivalent).
• Ensure alignment with GMP, data integrity expectations, and site quality standards.
• Link change controls to deviations and CAPAs when applicable and ensure timeline alignment.
• Coordinate validation and qualification impact assessments (IQ, OQ, PQ, CSV, requalification).
• Lead cross‑functional working sessions and provide concise weekly status reporting.
• Identify recurring issues and propose continuous improvement initiatives to simplify and strengthen change control processes.

Must Have

• 5–7 years of experience in a regulated pharmaceutical, biotechnology, or medical device environment.
• Strong hands‑on experience executing change controls within a Quality Management System.
• Solid knowledge of GMP and audit‑ready documentation practices.
• Proven ability to lead cross‑functional discussions and drive actions to closure.
• Leadership experience or strong leadership capability.
• Ability to work on‑site in Toronto most days, preferably daily at the beginning.

Nice to Have

• Experience with deviations, CAPAs, investigations, and root cause analysis.
• Validation exposure (CSV and/or Commissioning & Qualification).
• Experience in sterile manufacturing, biologics, vaccines, or high‑containment environments.
• Familiarity with quality metrics, trackers, dashboards, and right‑first‑time documentation approaches.

50K–110K. The final compensation offered will be determined based on the candidate’s level of experience, skills, and qualifications, in compliance with applicable pay transparency requirements.

No Canadian work experience is required for this position. Candidates are encouraged to apply regardless of previous Canadian experience.

No Artificial Intelligence (AI) tools are used in the screening, assessment, or selection of candidates for this position. All stages of the recruitment process are conducted by human recruiters and hiring managers.

This position is a job creation, created to support ongoing project needs. (Job creation for KP)

Candidates will receive feedback on their application within a maximum of 45 days from the date of application or from their most recent interview stage.

• An international community bringing together more than 110 different nationalities.
• An environment where trust is central: 70% of our leaders started their careers at the entry level.
• A strong training system with our internal Academy and more than 250 modules available.
• A dynamic work environment that frequently comes together for internal events (after works, team buildings, etc.).

Amaris Consulting promotes equal opportunities. We are committed to bringing together people from diverse backgrounds and creating an inclusive work environment. In this regard, we welcome applications from all qualified individuals, regardless of sex, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.