Catalent Pharma Solutions
Director, Quality
Catalent Pharma Solutions, Princeton, New Jersey, us, 08543
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.Our Princeton, NJ site is part of Catalent's cell therapy network. The CGMP manufacturing facility is equipped with 16 flexible clean rooms, QC labs, and warehouse space to support late-stage and commercial-scale autologous and allogeneic cell therapy production.The Role
The Director, Quality is responsible for setting the strategic direction, properly staffing, and maintaining the Quality Management Systems (QMS) to ensure the site is in compliance with regulatory, Corporate, and customer requirements. This role is responsible for establishing and maintaining the site metrics, management review, and building a Patient First culture at the site. The Director of Quality is responsible for both Quality Assurance and Quality Control. This individual is the most responsible person for batch disposition, is responsible for providing project guidance/support, and will work with customers to resolve quality concerns as appropriate.Serve as the site's primary contact (with both customers and regulatory agencies) for the site Quality Unit.Develop and implement Site Quality Plan, Quality Unit objectives and related procedures.Maintain an effective Quality Management System (QMS) that aligns with regulatory requirements/expectations.Monitor site compliance to FDA, EU and all other applicable requirements.Interface with all other departments to ensure compliance with cGMP.Ensure site procedures align with Corporate policies.Direct a team of Quality professionals. Provide development and disciplinary actions (as needed) to ensure the department remains engaged and motivated.Ensure regulatory and customer audits are managed successfully and any responses submitted in a timely manner.Analyze, resolve, or assist in solving compliance and customer issues.Prepare, approve, and manage Quality departmental budget.Approve or reject, starting materials, packaging materials, and intermediate, finished products, and to evaluate batch production records.Ensure Quality approval of specifications, sampling instructions, test methods and other Quality Control procedures.Ensure that Document Control activities are compliant with FDA, EU and other applicable requirements.All other duties as assigned.The Candidate
Bachelor’s degree in chemistry or closely related field (e.g. natural sciences, engineering).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 with Cell Therapy is preferred.Experience leading a manufacturing site operation (e.g. Quality Operations, QC Operations, Manufacturing) is strongly preferred.Ability to work in a start-up business and have the mindset of growth.Knowledge of cGMP, ICH, and other non-US regulations / guidelines; demonstrated experience applying them to both cGMP manufacturing and/or QC lab environments.Demonstrable leadership experience at Catalent may be considered in place of external experience.Why You Should Join Catalent
Defined career path and annual performance review and feedback process.Diverse, inclusive culture.Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.Dynamic, fast-paced work environment.Community engagement and green initiatives.Generous 401K match and Paid Time Off accrual.Medical, dental and vision benefits effective day one of employment.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 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.Catalent is an Equal Opportunity Employer, including disability and veterans.
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The Director, Quality is responsible for setting the strategic direction, properly staffing, and maintaining the Quality Management Systems (QMS) to ensure the site is in compliance with regulatory, Corporate, and customer requirements. This role is responsible for establishing and maintaining the site metrics, management review, and building a Patient First culture at the site. The Director of Quality is responsible for both Quality Assurance and Quality Control. This individual is the most responsible person for batch disposition, is responsible for providing project guidance/support, and will work with customers to resolve quality concerns as appropriate.Serve as the site's primary contact (with both customers and regulatory agencies) for the site Quality Unit.Develop and implement Site Quality Plan, Quality Unit objectives and related procedures.Maintain an effective Quality Management System (QMS) that aligns with regulatory requirements/expectations.Monitor site compliance to FDA, EU and all other applicable requirements.Interface with all other departments to ensure compliance with cGMP.Ensure site procedures align with Corporate policies.Direct a team of Quality professionals. Provide development and disciplinary actions (as needed) to ensure the department remains engaged and motivated.Ensure regulatory and customer audits are managed successfully and any responses submitted in a timely manner.Analyze, resolve, or assist in solving compliance and customer issues.Prepare, approve, and manage Quality departmental budget.Approve or reject, starting materials, packaging materials, and intermediate, finished products, and to evaluate batch production records.Ensure Quality approval of specifications, sampling instructions, test methods and other Quality Control procedures.Ensure that Document Control activities are compliant with FDA, EU and other applicable requirements.All other duties as assigned.The Candidate
Bachelor’s degree in chemistry or closely related field (e.g. natural sciences, engineering).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 with Cell Therapy is preferred.Experience leading a manufacturing site operation (e.g. Quality Operations, QC Operations, Manufacturing) is strongly preferred.Ability to work in a start-up business and have the mindset of growth.Knowledge of cGMP, ICH, and other non-US regulations / guidelines; demonstrated experience applying them to both cGMP manufacturing and/or QC lab environments.Demonstrable leadership experience at Catalent may be considered in place of external experience.Why You Should Join Catalent
Defined career path and annual performance review and feedback process.Diverse, inclusive culture.Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.Dynamic, fast-paced work environment.Community engagement and green initiatives.Generous 401K match and Paid Time Off accrual.Medical, dental and vision benefits effective day one of employment.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 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.Catalent is an Equal Opportunity Employer, including disability and veterans.
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