Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here
The Associate Director, Client QA provides strategic oversight and leadership to QA operations, to ensure project objectives are met to a high-quality standard and according to commitments while ensuring current Good Manufacturing Practices (cGMPs) compliance for manufacturing of biological product, and compliance to US and EU regulations, as applicable.
The primary responsibilities of this position include providing direction for programs, processes and team members of the department, as well as setting the tone for compliance and on time delivery of department deliverables. This position plays a key role defining the values, culture, and goals for the site
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.
- Responsible for staffing and overseeing training, effective execution of responsibilities, professional development of employees and conducting performance reviews
- Outlines and executes on department and business objectives, identifying continuous improvement initiatives, monitors progress of deliverables, and provides support to staff to ensure success
- Responsible for quality oversight of new facility build and expansion, coordinating QA validation support.
- Directs the batch record review and lot disposition activities to ensure product delivery in compliance with applicable regulatory submissions and approvals and within prescribed timelines
- Member of the Quality leadership team, participate in the Quality Metric review process, assess data for adverse trends, develop solutions and oversee implementation related to area
- Facilitates QA support and works closely with other Catalent functional units including Manufacturing, Validation, Facilities Engineering, and Quality Control to assess and resolve quality issues with regards to the facility and products manufactured
- Resolves and assists in solving compliance and customer issues
- Develops and implements procedures, programs and policies that support GMP operations and overall compliance strategy
- Serve as team leader in quality investigations and ensure corrective and/or preventive action plans to resolve potential product quality and compliance issues are appropriately implemented
- Continuous review of all systems and procedures (SOPs) for efficiency, best practices and regulatory compliance improvements and adherence with Corporate policies.
- Work with senior management to initiate new client proposals and projects. This includes analyzing client proposals for resource allocation and QA costs generated by Business Development.
- Bachelors Degree in Science or related field required (Chemistry, Microbiology or Biology preferred)
- 9+ years of relevant work experience in pharmaceuticals, preferably biotechnology within a Quality role
- 7+ years of leadership experience including performance management
- Comprehensive and practical working knowledge of applicable GMP regulations, ICH guidelines, FDA guidelines, USP, EP, JP and other applicable regulations and guidance
- Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish. Exposure to contract manufacturing a plus.
- Ability to quickly learn new and novel manufacturing processes supporting new clients
- Ability to self-direct, and adapt to changing priorities
- Excellent communication and interpersonal skills required
- Strong attention to detail and organization skills required
- Proven technical writing and editing skills
- Cr e a t i v e indi v idua l w i th ex c e ll e n t problem solving and t r o ubl e s h o o t in g sk il l s
- Ability to work effectively under pressure to meet deadlines
- Potential for career growth within an expanding team
- Defined career path and annual performance review & feedback process
- Cross functional exposure to other areas of within the organization
- Medical, Dental, Vision, and 401K are all offered from day one of employment
- 19 days of paid time off annually + 8 paid holidays