Specialist, Compliance

Join a Leader in Pharmaceutical Manufacturing — And Build What’s NextJubilant 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 PlaceIf 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.
If you want to
build something meaningful
with a team that values your drive, skills, and ideas — you belong here.
Purpose of the JobThe 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 proactively identified, tracked, and addressed in alignment with internal Quality Systems and external regulatory expectations.
Location: Kirkland (West Island), Qc. — On Site, Full-TimeKey AccountabilitiesA. 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.
B. Regulatory CAPA Follow-Up & Compliance Tracking
Track and follow up on regulatory and internal audit CAPAs to ensure timelyand 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 to identify recurring or systemic risks.
C. 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 escalatedidentifiedgaps, risks, or emerging compliance concerns.
Support the development and tracking of remediation actions arising from gap assessments.
D. 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 escalates risks to Quality Systems leadership.
E. 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 is accurate, current, and inspection-ready.
F. 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.
G. Other Responsibilities
Perform other compliance-related tasks as assigned by Quality Systems & Compliance Management.
Participate in continuous improvement initiatives to strengthen compliance maturity.
Education Qualifications
Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or a related scientific discipline
Experience Required
Minimum of five (5) years of experience inQuality in thepharmaceutical industry
Experience in a sterile manufacturing facility (additional preferred experience)
Skills Required
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
Compensation & Benefits That Start on Day One — Because Your Well Being MattersAt 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
Life Insurance
Short-Term & Long-Term Disability Insurance
Unlock Your PotentialIf you’re seeking a dynamic and rewarding career, we welcome your application today.
#J-18808-Ljbffr