Compliance Manager

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

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 DisabilityAccommodations@catalent.com. 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.

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