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Director of Quality Assurance
2 months ago
Catalent is a global leader in the development and manufacturing of new treatments for patients worldwide. As a Director, Quality, you will play a critical role in ensuring the site's Quality Management Systems (QMS) are in compliance with regulatory, Corporate, and customer requirements.
The RoleAs the site's primary contact for Quality, you will develop and implement the Site Quality Plan, Quality Unit objectives, and related procedures. You will maintain an effective QMS that aligns with regulatory requirements and expectations, monitor site compliance to FDA, EU, and other applicable requirements, and interface with all departments to ensure compliance with cGMP.
Responsibilities- Develop and implement the Site Quality Plan, Quality Unit objectives, and related procedures
- Maintain an effective QMS that aligns with regulatory requirements and expectations
- Monitor site compliance to FDA, EU, and other applicable requirements
- Interface with all departments to ensure compliance with cGMP
- Direct a team of Quality professionals and provide development and disciplinary actions as needed
- Ensure regulatory and customer audits are managed successfully and responses are submitted in a timely manner
- Analyze, resolve, or assist in solving compliance and customer issues
- Prepare, approve, and manage the Quality departmental budget
- Approve or reject starting materials, packaging materials, and intermediate, finished products, and evaluate batch production records
- Ensure Quality approval of specifications, sampling instructions, test methods, and other Quality Control procedures
- Ensure Document Control activities are compliant with FDA, EU, and other applicable requirements and controlled documents are maintained in an orderly manner
- Bachelor's degree in chemistry or a closely related field
- 10-12 years' directly related experience in pharmaceutical fields, including managerial roles
- Experience with sterile drug product manufacturing and drug substance manufacturing is strongly preferred
- Experience leading a manufacturing site operation is strongly preferred
- Ability to work in a start-up business and have a growth mindset
- Knowledge of cGMP, ICH, and other non-US regulations/guidelines, and demonstrated experience applying them to cGMP manufacturing and/or QC lab environments
Catalent offers a dynamic, fast-paced work environment, a diverse and inclusive culture, and opportunities for career growth on an expanding team. We provide a generous 401K match, paid time off, medical, dental, and vision benefits, tuition reimbursement, and a defined career path with annual performance reviews and feedback.
Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, please submit your request by sending an email to DisabilityAccommodations@catalent.com.
