Catalent Pharma Solutions
Director, QA Batch Release
Catalent Pharma Solutions, Harmans, Maryland, United States, 21077
Director, QA Batch Release
Position SummaryCatalent 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.The Director, Quality Assurance Batch Release provides strategic oversight and leadership to QA Batch Record Review and Release supporting clinical and commercial drug substance and drug product manufacturing. The Director ensures 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 products, and compliance to US, EU regulations, and other Boards of Health (BOH) as applicable.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.The RoleDirects the batch record review and lot disposition activities to ensure product delivery in compliance with applicable regulatory submissions and approvals and within prescribed timelines.Outlines and executes on department and business objectives, identifying continuous improvement initiatives, monitors progress of deliverables, and provides support to staff to ensure success.Provides strategic oversight and leadership to client representatives to ensure project objectives are met to a high-quality standard and according to commitments. Resolves and assists in solving compliance and customer issues.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.Develops and implements procedures, programs and policies that support GMP operations and overall compliance strategy.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.The CandidateBachelors Degree in Science or related field required (Chemistry, Microbiology or Biology preferred).10+ years of relevant work experience in pharmaceuticals, preferably biotechnology within a Quality role.8+ 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 while working effectively under pressure to meet deadlines.Excellent communication/interpersonal skills, strong attention to detail, proven technical writing and editing skills.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.PayThe anticipated salary range for this position in Maryland is $188,320 - $258,940 plus variable incentive compensation. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc.Why You Should Join CatalentDefined 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.
#J-18808-Ljbffr
Position SummaryCatalent 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.The Director, Quality Assurance Batch Release provides strategic oversight and leadership to QA Batch Record Review and Release supporting clinical and commercial drug substance and drug product manufacturing. The Director ensures 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 products, and compliance to US, EU regulations, and other Boards of Health (BOH) as applicable.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.The RoleDirects the batch record review and lot disposition activities to ensure product delivery in compliance with applicable regulatory submissions and approvals and within prescribed timelines.Outlines and executes on department and business objectives, identifying continuous improvement initiatives, monitors progress of deliverables, and provides support to staff to ensure success.Provides strategic oversight and leadership to client representatives to ensure project objectives are met to a high-quality standard and according to commitments. Resolves and assists in solving compliance and customer issues.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.Develops and implements procedures, programs and policies that support GMP operations and overall compliance strategy.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.The CandidateBachelors Degree in Science or related field required (Chemistry, Microbiology or Biology preferred).10+ years of relevant work experience in pharmaceuticals, preferably biotechnology within a Quality role.8+ 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 while working effectively under pressure to meet deadlines.Excellent communication/interpersonal skills, strong attention to detail, proven technical writing and editing skills.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.PayThe anticipated salary range for this position in Maryland is $188,320 - $258,940 plus variable incentive compensation. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc.Why You Should Join CatalentDefined 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.
#J-18808-Ljbffr