Specialist, Compliance
- Greater Montreal Metropolitan Area, QC, Canada
Full-time
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Original job description
Job Description
Job Title: Specialist, Compliance
Req Id: 1500
Posting Start Date: 11/3/26
Job Description:
Join a Leader in Pharmaceutical Manufacturing - And Build What’s Next
Jubilant HollisterStier LLC is a well-established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support life-changing medicines around the world. We are nationally recognized for our expertise in producing sterile injectable vials and lyophilized products, and our Allergy business is a global leader in allergenic extracts that support treatments for allergies and asthma. Jubilant HollisterStier is proudly part of the global, Jubilant Pharma family.
For the Builders, Innovators, and Doers - This Is Your Place
If you are someone who thrives on solving complex problems, improving systems, and building real solutions, you’ll feel at home here. At Jubilant HollisterStier, your ideas matter - and your impact is felt globally.
Why builders choose us:
Purpose of the Job:
The Specialist, Compliance supports the Quality Systems & Compliance function by monitoring,maintaining, and strengthening site compliance with GMP and regulatory requirements.This role focuses on audit readiness, regulatory compliance monitoring, supplier quality oversight, regulatory CAPA follow-up, and regulatory surveillance, ensuring that compliance risks are proactivelyidentified, tracked, and addressed in alignment with internal Quality Systems and external regulatory expectations.
Location: Kirkland (West Island), Qc. - On Site, Full-Time
Key Accountabilities:
At Jubilant HollisterStier, we don’t believe in waiting periods. From the moment you join us, you and your family have access to a full suite of benefits designed to support your health, stability, and long-term success.
Starting on your first day, you receive:
If you’re seeking a dynamic and rewarding career, we welcome your application today.
Job Title: Specialist, Compliance
Req Id: 1500
Posting Start Date: 11/3/26
Job Description:
Join a Leader in Pharmaceutical Manufacturing - And Build What’s Next
Jubilant HollisterStier LLC is a well-established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support life-changing medicines around the world. We are nationally recognized for our expertise in producing sterile injectable vials and lyophilized products, and our Allergy business is a global leader in allergenic extracts that support treatments for allergies and asthma. Jubilant HollisterStier is proudly part of the global, Jubilant Pharma family.
For the Builders, Innovators, and Doers - This Is Your Place
If you are someone who thrives on solving complex problems, improving systems, and building real solutions, you’ll feel at home here. At Jubilant HollisterStier, your ideas matter - and your impact is felt globally.
Why builders choose us:
- Immediate impact: Your work directly supports essential medicines and allergenic therapies used worldwide.
- Benefits start on day one: Medical, Dental, Vision, Life Insurance, and Disability benefits begin immediately because your well-being shouldn’t have a waiting period.
- A career you can grow: We provide opportunities for growth, promotion, and annual raises, with midpoint compensation reserved for high performance and longevity.
- A culture of improvement: We value people who thrive on continuous improvement, innovation, and hands on contribution.
- A stable industry leader: Backed by Jubilant Pharma, we pair long-term stability with forward looking innovation.
Purpose of the Job:
The Specialist, Compliance supports the Quality Systems & Compliance function by monitoring,maintaining, and strengthening site compliance with GMP and regulatory requirements.This role focuses on audit readiness, regulatory compliance monitoring, supplier quality oversight, regulatory CAPA follow-up, and regulatory surveillance, ensuring that compliance risks are proactivelyidentified, tracked, and addressed in alignment with internal Quality Systems and external regulatory expectations.
Location: Kirkland (West Island), Qc. - On Site, Full-Time
Key Accountabilities:
- Compliance Monitoring & Audit Readiness
- Support site audit readiness activities, including document reviews, compliance walkthroughs, and readiness assessments.
- Participate in internal audits, self-inspections, and GMP health checks.
- Support preparation for regulatory inspections and corporate audits.
- Assistin drafting, reviewing, and tracking responses to audit and inspection observations.
- Monitor implementation and completion of actions resulting from audits and inspections.
- Regulatory CAPA Follow-Up & Compliance Tracking
- Track and follow up on regulatory and internal audit CAPAs to ensuretimelyand effective completion.
- Verify that corrective and preventive actions are appropriately documented and aligned with commitments.
- Support effectiveness checks and documentation of CAPA outcomes.
- Trend audit observations, CAPAs, and compliance issues toidentifyrecurring or systemic risks.
- Regulatory Surveillance & Gap Assessments
- Support regulatory intelligence and surveillance activities by monitoring updates to applicable GMP regulations, guidance, and standards.
- Participate in regulatory gap assessments to evaluate site alignment with evolving expectations.
- Document and escalateidentifiedgaps, risks, or emerging compliance concerns.
- Support the development and tracking of remediation actions arising from gap assessments.
- Supplier Quality & External Compliance Support
- Support supplier quality management activities in collaboration with Supplier Quality and Procurement.
- Participate in supplier audits, assessments, or documentation reviews asrequired.
- Track and follow up on supplier-related quality issues, audit findings, and CAPAs.
- Support review and maintenance of Quality Agreements from a compliance perspective.
- Monitor supplier compliance status and escalate risks to Quality Systems leadership.
- Compliance Metrics & Reporting
- Support collection and maintenance of compliance KPIs (e.g., audit findings, CAPA status, overdue actions).
- Prepare compliance dashboards and reports for Quality management review.
- Ensure compliance data isaccurate, current, and inspection-ready.
- Documentation & Quality System Support
- Support maintenance of Quality System documentation related to compliance processes.
- Ensure compliance records and evidence are complete, traceable, and aligned with data integrity principles.
- Assistwith controlled document updates related to compliance activities.
- Other Responsibilities
- Perform other compliance-related tasks as assigned by Quality Systems & Compliance Management.
- Participate in continuous improvement initiatives to strengthen compliance maturity.
- Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or a related scientific discipline
- Minimum of five (5) years of experience inQuality in thepharmaceutical industry
- Experience in a sterile manufacturing facility (additional preferred experience).
- Working knowledge of GMP regulations (Health Canada, FDA, EU)
- Understanding of Quality Management Systems and compliance principles
- Ability to interpret regulatory requirements and internal procedures
- Bilingual (French and English); Englishproficiencyrequired
- Strong organization and follow-up skills
- Attention to detail and documentation quality
- Ability to manage multiple priorities and timelines
- Clear and professional communication
At Jubilant HollisterStier, we don’t believe in waiting periods. From the moment you join us, you and your family have access to a full suite of benefits designed to support your health, stability, and long-term success.
Starting on your first day, you receive:
- Medical, Dental & Vision coverage
- Life Insurance
- Short-Term & Long-Term Disability Insurance
If you’re seeking a dynamic and rewarding career, we welcome your application today.
More about this job
Responsibilities
Support site compliance with GMP and regulatory requirements through audit readiness, regulatory monitoring, supplier quality oversight, and CAPA follow-up. Track compliance risks and actions, maintain inspection-ready records, and prepare metrics and reports for Quality management.
Requirements
A bachelor’s degree in Life Sciences, Engineering, Pharmacy, or a related scientific discipline and at least five years of pharmaceutical Quality experience are required. Candidates should have working knowledge of GMP regulations and Quality Management Systems, strong organizational and documentation skills, and proficiency in both French and English; sterile manufacturing experience is preferred.
Skills
- GMP Compliance
- Regulatory Compliance Monitoring
- Audit Readiness
- Internal Audits
- Regulatory Inspections
- CAPA Tracking
- Regulatory Surveillance
- Gap Assessments
- Supplier Quality Management
- Quality Agreements
- Compliance Metrics and Reporting
- Quality Management Systems
- Data Integrity
- Documentation Management
- Risk Assessment
- Bilingual Communication
Benefits
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Short-Term Disability Insurance
- Long-Term Disability Insurance
Visa sponsorship
Not detected in the job text
Categories
- Manufacturing
- Healthcare
- Science & Research
Keywords
- Good Manufacturing Practices
- Health Canada
- FDA
- European Union GMP
- Quality Systems
- Quality Management Systems
- Audit Readiness
- Internal Audits
- Self-Inspections
- Regulatory Inspections
- Corrective and Preventive Actions
- CAPA
- Regulatory Surveillance
- Regulatory Intelligence
- Gap Assessments
- Supplier Quality
- Supplier Audits
- Quality Agreements
- Compliance KPIs
- Compliance Dashboards
- Data Integrity
- Controlled Documents
- Pharmaceutical Manufacturing
- Sterile Manufacturing
- Continuous Improvement