Catalent Inc
Director, QA Batch Release
Catalent Inc, Maryland Line, Maryland, us, 21105
Director, Quality Assurance Batch Release
Position Summary
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.
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 Role
The primary responsibilities of this position include providing direction for programs, processes and team members of the department, related to batch record review and disposition supporting clinical and commercial drug substance and drug product manufacturing. The Director, Quality Assurance Batch Release serves as the Quality counterpart for the Senior Director, Commercial Operations in managing the activities of the Commercial Vertically Integrated Team (cVIT) as well as setting the tone for compliance and on time completion of department deliverables. This position plays a key role defining the values, culture, and goals for the site.
Directs the batch record review and lot disposition activities to ensure product delivery in compliance with applicable regulatory submissions and approvals and within prescribed timelinesOutlines and executes on department and business objectives, identifying continuous improvement initiatives, monitors progress of deliverables, and provides support to staff to ensure successProvides 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 issuesParticipate in the Quality Metric review process, assess data for adverse trends, develop solutions and oversee implementation related to areaFacilitates 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 manufacturedDevelops and implements procedures, programs and policies that support GMP operations and overall compliance strategyContinuous 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 Candidate
Bachelors 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 role8+ years of leadership experience including performance managementComprehensive and practical working knowledge of applicable GMP regulations, ICH guidelines, FDA guidelines, USP, EP, JP and other applicable regulations and guidanceKnowledgeable 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 clientsAbility to self-direct and adapt to changing priorities while working effectively under pressure to meet deadlinesExcellent communication/interpersonal skills, strong attention to detail, proven technical writing and editing skillsDemonstrable 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 experiencePay
The 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. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.
Why You Should Join Catalent
Defined career path and annual performance review and feedback processDiverse, inclusive culturePotential for career growth on an expanding team within an organization dedicated to preserving and bettering livesDynamic, fast-paced work environmentCommunity engagement and green initiativesGenerous 401K match and paid time off accrualMedical, dental, and vision benefits effective day one of employmentTuition 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 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.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
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, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
Position Summary
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.
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 Role
The primary responsibilities of this position include providing direction for programs, processes and team members of the department, related to batch record review and disposition supporting clinical and commercial drug substance and drug product manufacturing. The Director, Quality Assurance Batch Release serves as the Quality counterpart for the Senior Director, Commercial Operations in managing the activities of the Commercial Vertically Integrated Team (cVIT) as well as setting the tone for compliance and on time completion of department deliverables. This position plays a key role defining the values, culture, and goals for the site.
Directs the batch record review and lot disposition activities to ensure product delivery in compliance with applicable regulatory submissions and approvals and within prescribed timelinesOutlines and executes on department and business objectives, identifying continuous improvement initiatives, monitors progress of deliverables, and provides support to staff to ensure successProvides 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 issuesParticipate in the Quality Metric review process, assess data for adverse trends, develop solutions and oversee implementation related to areaFacilitates 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 manufacturedDevelops and implements procedures, programs and policies that support GMP operations and overall compliance strategyContinuous 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 Candidate
Bachelors 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 role8+ years of leadership experience including performance managementComprehensive and practical working knowledge of applicable GMP regulations, ICH guidelines, FDA guidelines, USP, EP, JP and other applicable regulations and guidanceKnowledgeable 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 clientsAbility to self-direct and adapt to changing priorities while working effectively under pressure to meet deadlinesExcellent communication/interpersonal skills, strong attention to detail, proven technical writing and editing skillsDemonstrable 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 experiencePay
The 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. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.
Why You Should Join Catalent
Defined career path and annual performance review and feedback processDiverse, inclusive culturePotential for career growth on an expanding team within an organization dedicated to preserving and bettering livesDynamic, fast-paced work environmentCommunity engagement and green initiativesGenerous 401K match and paid time off accrualMedical, dental, and vision benefits effective day one of employmentTuition 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 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.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
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, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.