Director of Quality, Consumer Health Canada

5 months ago

Strathroy, Canada Catalent Full time

**Position Summary**:
Reporting to the Vice President Quality, Consumer Health and as a member of the Canadian Site Leadership Team this position is accountable for the direct management and guidance in the Quality and cGMP aspects of the organization. The Director of Quality will work closely with the SLT, their direct reports and federal regulators in the development, roll-out and management of corporate policies through compliance needs and current Good Manufacturing Practice (cGMP) guidelines. They will also ensure through their oversight of their team, that site-specific quality systems and procedures for submitting research and development data (technology transfer), conducting investigations, generating site and corporate quality metrics are established and followed. It is through their personal and team’s efforts, that both internal customers and external regulators will view the Canadian Catalent Quality Systems and team positively.

**The Role**:

- Responsible for ensuring that the necessary systems are in place to support compliance with cGMP for the Canadian Catalent facilities, processes and people for the markets in which its products are sold.
- Ensure compliance assessments of Catalent Ontario are appropriately managed and that responses to resolve deficiencies are provided and communicated in a timely manner.
- Final decisions regarding product quality and on product disposition.
- Mentor, lead and provide adequate, trained personnel to support the production and packaging activities and the testing of raw materials, components, and labeling, intermediate and finished goods in line with the supply plan.
- Ensure that the direct and support responsibilities of the Quality groups are delivered in a cost-effective manner and appropriately balance risk and reward.
- Provide leadership within Quality for cross-functional initiatives aimed at improving corporate efficiency and effectiveness.
- Establish individual performance expectations for direct reports and regularly evaluate their performance against objectives.

Shared Responsibilities:

- Ensure Quality representation for the supply planning portion of the S&OP process and other PLCM events (eg. planned changes).
- Ensure alignment of Quality, Operations, and Product Development on key
- Bachelor’s degree in Life Sciences or related field required. Master’s Degree preferred.
- 15 plus years of experience in the pharmaceutical industry including ten years in a leadership role.
- Strong knowledge of Canadian, US and EU regulatory guidelines, agencies and their senior contacts/people.
- Extensive relevant experience in pharmaceutical manufacturing.
- Significant career experience with established contract manufacturing organizations.
- Knowledge of local, provincial, federal regulations and laws governing business operations of a pharmaceutical manufacturing facility.
- Excellent management and organizational skills.
- Demonstrated ability to lead a team and achieve results.
- Experience in budgeting and proven ability to manage multiple projects and meet deadlines. Quality Processes and issues.
- Support on-time launch of products.
- Ensure best practices are applied within Quality.
- Functional talent management and HR planning.
- Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

**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, and personal time.
- Employee Reward and Recognition Programs.
- Opportunities for professional and personal development.

**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 Emp

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