Compliance Manager Jobs

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 Strathroy 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.

This position is located in Strathroy, Ontario, 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.

Regular working hours: 8:00 AM – 4:30 PM or 8:30 AM – 5:00 PM with a 30-minute unpaid lunch.

The Role

• Develop and deliver enhanced and effective cGMP Training.
• 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.
• 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.
• 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.
• 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.
• Other duties and projects as assigned.

The Candidate

• There is also the potential exposure to chemicals.
• Knowledge and experience in dosage forms involving gelatin encapsulation is an asset.
• Ability to multi-task and prioritize.
• 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.
• 5+ years of management level experience in pharmaceutical industry.
• Ability to respond quickly and to a changing regulatory environment
• 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.
• Experience working in a manufacturing, pharmaceutical and/or GMP facility.
• Expertise in contemporary tools to meet current and advancing cGMP requirements.
• Bachelor's Degree in a pertinent Scientific or Engineering field is required.
• Understanding of the overall business needs and objectives.
• Direct experience hosting and leading the preparation, management, and follow-up relating to FDA and HPFBI inspections.
• Excellent verbal and written communication skills.

Why You Should Join Catalent

• Group Retirement Savings –Registered Pension Plan (RPP) with employer contributions
• Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance)
• Opportunities for professional and personal development & growth including tuition reimbursement
• Employee Reward & Recognition programs
• Paid Time Off Programs including vacation, banked time & personal time

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.