Quality Assurance Compliance Manager

**Quality Assurance Compliance Manager**

**Position Summary**:
Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

Reporting to the Director of Quality, Consumer Health Canada, this position 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 Commercial Product stability, SOP, Change Management, Master Document Maintenance and Control, Annual Product Review, and Customer Complaint Investigation programs.

This position can be located in Strathroy, Ontario or Windsor, Ontario, our 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**:

- Host and directly manage 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.
- Manage the Strathroy and corporate self-inspection and compliance monitoring program.
- Lead the implementation of new, and improvement of existing, Quality Systems to ensure these are both compliant and effective, with a particular focus to the development of systems for newer service offerings as they are introduced, and emerging trends in existing systems.
- Manage the Commercial drug product Stability Program, ensuring compliant and efficient preparation of protocols, pulls of samples, execution of testing, investigations of OOS's, and preparation and approval of reports. The program allows for the provision of scientifically valid data to support shelf-life expectations and resulting shelf-life assignment decisions by the Customer/Client for Catalent manufactured products.
- Manage the Customer Complaint Investigation process, ensuring that it able to identify, prioritize, and quantitate the most significant outgoing product quality issues resulting in customer complaints and rejections. Establish and lead the company process improvement teams to address the product and process quality issues that have been identified and provide oversight for the Annual Product Review program ensuring deliverables are on time and value-added time a process knowledge and control perspective.
- Work closely with the operations team to ensure that the Quality Management System and Quality Plan supports current Quality Management strategy theories, corporate objectives and industry requirements and develop and deliver enhanced and effective cGMP Training.
- Develop and maintain metrics to measure effectiveness of key Quality KPIs.
- Other duties and projects as assigned.
- Bachelor's Degree in a pertinent Scientific or Engineering field is required.
- 5+ years of management level experience in quality related roles for consumer health products is required.
- Experience working in a manufacturing, pharmaceutical and/or GMP facility is preference.
- 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

**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 including vacation, banked time & personal time.
- Employee Reward & Recognition programs.
- Opportunities for professional and personal development & growth including 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 compan