Join Pillar5 Pharma and be part of a company dedicated to producing high-quality sterile ophthalmic products that improves patients’ vision and quality of life. From our facility in Arnprior, our team provides a supportive environment where you will gain valuable industry experience and have opportunities to develop your skills and advance your career within the organization.
The Quality Compliance Manager is responsible for ensuring GMP compliance for materials, products, and processes. This includes overseeing the QC department, managing the stability program, supervising analytical investigations, and supporting the introduction of new products. The manager will ensure proper training of QC staff, timely closure of CAPAs, change controls (CCs) and deviations, and will oversee the release of raw materials, semi-finished goods, and finished products. This role also involves managing GMP documentation, audits, and interdepartmental coordination to maintain compliance and operational efficiency. Additionally, the Quality Compliance Manager will be responsible for troubleshooting lab issues, ensuring smooth scheduling for QC testing, and supporting quality agreements with customers.
Key Responsibilities:
- Ensure compliance with GMP standards for testing and release of incoming components, raw materials, semi-finished goods, finished products, and stability testing.
- Lead and supervise the QC department, ensuring proper training, performance evaluations, and adherence to quality standards.
- Oversee the stability program, including shelf-life protocols, software setup, and coordination with QC lab analysts to ensure product stability.
- Oversee analytical investigations, ensuring proper execution, documentation, and closure of CAPAs, CCs, and deviations.
- Act as a point of contact for troubleshooting lab-related issues and driving continuous process improvements.
- Provide analytical testing support for new product introductions/product transfers and ensure alignment with GMP compliance.
- Approve specifications, APRs, and the accuracy of GMP documentation, including LIM system updates and customer agreements.
- Support regulatory audits by ensuring timely responses, accurate documentation, and corrective actions.
- Coordinate QC testing schedules, balancing manufacturing priorities with QC workload, and ensuring efficient use of resources.
- Oversee instrument qualifications and manage vendor relationships, including service contracts and maintenance.
Qualifications and Requirements:
- University Degree or college diploma in a relevant scientific discipline (chemistry preferred.
- A minimum of 10 years’ experience in pharmaceutical manufacturing environment and proven drug formulation expertise, particularly in ophthalmic formulations.
- A minimum of 2 years of leadership experience in a supervisory role with direct reports.
- Excellent communication, interpersonal and customer service skills..
- Experience with analytical testing support for new-product introductions/ product transfers, while aligning with GMP compliance.
- Analytical investigation experience while ensuring proper execution, documentation, and closure of CAPAs, CCs, and deviations.
This posting is for an existing vacancy. Pillar5 Pharma does not use AI at any stage of the recruitment or hiring process. Pillar5 Pharma is committed to diversity, inclusion, and equal opportunity in the workplace. Accommodations are available upon request throughout the recruitment and selection process.
Pay: $91,000.00-$102,000.00 per year
Benefits:
- Casual dress
- Company events
- Company pension
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Life insurance
- On-site parking
- Vision care
- Wellness program
Ability to commute/relocate:
- Arnprior, ON: reliably commute or plan to relocate before starting work (required)
Education:
Experience:
- pharmaceutical manufacturing: 10 years (required)
- Leadership: 2 years (required)
Work Location: In person
