Compliance Manager
Windsor, Ontario is one of two sites located in Canada offering softgel development and manufacturing capabilities for the Pharmaceutical and Consumer Health industries. We have a broad range of integrated formulation, manufacturing, analytical and packaging services to offer full-service turnkey solutions.
Position Summary
Reporting to the Director of Quality, Consumer Health Canada, the Compliance Manager is accountable for the management, monitoring, improvement, and development of quality systems and programs that are applicable to all company sites and the Windsor compliance program, to ensure continuing adherence to regulatory and customer cGMP standards. Specifically, this position has direct oversight of the quality agreements with customers and vendors, vendor qualification program of raw materials and components, self-inspection program, and hosting and leading all regulatory inspections.
The Role
- Host and oversee regulatory and customer audits. Prepare and facilitate responses to the observations arising from these audits and manage the follow up and closure of the corrective actions.
- Negotiates and approves quality agreements with customers and vendors to ensure quality standards and expectations are mutually agreed to and in line with the defined specification to assure quality of the product. Ensures quality agreements are maintained and up to date.
- Direct oversight of the vendor qualification program of raw materials and components to ensure incoming products meets the highest level of quality standards. Identify gaps and develop action plan to mitigate these gaps with the vendors prior to vendor approval. Ensure ongoing maintenance of the vendor qualification program throughout the relationship with the vendor.
- Maintain the vendor audit schedule and perform on-site audit of vendors as defined in the vendor qualification program and quality agreement with customers.
- Work closely with the operations team to ensure that the quality management system and quality plan supports current quality management strategy themes, corporate objectives, and industry requirements.
- Develop and deliver enhanced and effective cGMP Training.
- Other duties and projects as assigned.
The Candidate
- Bachelor's Degree in a pertinent Scientific or Engineering field is required.
- 5+ years of management level experience in pharmaceutical industry.
- Experience working in a manufacturing, pharmaceutical and/or GMP facility.
- Knowledge and experience in dosage forms involving gelatin encapsulation is an asset.
- Understanding of the overall business needs and objectives
- Expertise in contemporary tools to meet current and advancing cGMP requirements.
- Excellent verbal and written communication skills.
- Direct experience hosting and leading the preparation, management, and follow-up relating to FDA and HPFBI inspections.
- Ability to multi-task and prioritize.
- Ability to respond quickly and to a changing regulatory environment
- The employee is often required to sit and use their hands and fingers, to handle or feel and to manipulate keys on a keyboard. Use of manual dexterity is required.
- The employee is occasionally required to stand, walk, reach with arms and hands, bend, or twist, and to stoop, kneel, crouch or crawl. Vision abilities required by this job include close vision.
- There is also the potential exposure to chemicals.
Position located in the Windsor facility with travels to the Strathroy facility in hosting and leading regulatory inspection.
Regular working hours: 8:00 AM – 4:30 PM or 8:30 AM – 5:00 PM with a 30-minute unpaid lunch.
Why you should join Catalent:
- Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance).
- Group Retirement Savings –Registered Pension Plan (RPP) with employer contributions.
- Paid Time Off Programs incl. vacation, banked time & personal time.
- Employee Reward & Recognition programs;
- Opportunities for professional and personal development & growth incl. tuition reimbursement