Director, Quality Assurance Operations

Company: Disability Solutions
Location: Severn
Posted on: September 3, 2024

Job Description:

Position SummaryThe Director, Quality Assurance Operations provides strategic oversight and leadership to QA operations supporting commercial activities including real-time batch record review, QA On the Floor (QA-OTF), deviation support and approval and client QA activities. The incumbent 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 product, and compliance to US, EU regulations, and other Boards of Health (BOH) regulations as applicable.The RoleThe primary responsibilities of the Director of Quality Assurance Operations include ensuring the proper staffing and direction for programs, processes, and team members of the department, related to real-time batch record review, QA-OTF support, and Client QA activities supporting commercial operations. The Director, Quality Assurance Operations serves as the Quality counterpart for the Senior Director, Commercial Operations for delivering the SQDC requirements and forecast as established and managing the activities of the Commercial Vertically Integrated Team (cVIT). This team partners with Operations and delivers on the expectations for operational excellence while maintaining the highest standards of quality and compliance. This team also acts as the customer advocate to drive the right actions and decisions to help customers properly execute and deliver their programs on time with the expected compliance. This often requires the ability to work in the gray areas and raise/negotiate difficult conversations and outcomes with customers. This position sets the tone for compliance while delivering the on-time completion of department deliverables. This position plays a key role in establishing, maintaining, and enforcing the Patient First culture, Catalent values, and goals for the site.

• Outlines and executes 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
• Directs the real-time batch record review activities to ensure product delivery in compliance with applicable regulatory submissions and approvals within prescribed timelines
• Provides investigation direction, support, and department approvals
• Ensures investigation CAPA actions are clearly defined, effective in resolving the root causes and are implemented timely
• Oversees client-facing personal supporting cVIT in the roles of Client QA
• Directs QA-OTF activities supporting commercial activities including central services and manufacturing operations
• Facilitates QA support and works closely with other Catalent cross-functional units including Manufacturing, Validation, Facilities Engineering, and Quality Control to assess and resolve quality issues with regard to the facility and products manufactured
• Develops and implements procedures, programs, and policies that support GMP operations and overall compliance strategy
• 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 DevelopmentThe Candidate
  • Bachelor's 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. Excellent communication and interpersonal skills required
  • Creative individual with excellent problem solving and troubleshooting skills
  • Ability to work effectively under pressure to meet deadlines
  • 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.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.
    • Cross-functional exposure to other areas within the organization.
    • 152 hours of paid time off annually + 8 paid holidays.
    • Medical, dental, vision and 401K benefits effective day one of employment.
    • Employee Stock Purchase Plan.
    • 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 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.--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. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.------personal initiative. dynamic pace. meaningful work.Visit 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 . 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 .

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