Vice President, Quality - Maryland

Company: Disability Solutions
Location: Severn
Posted on: February 3, 2025

Job Description:

Vice President, Quality - MarylandPosition SummaryCatalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.The Vice President, Quality is a key leadership position, who is accountable for ensuring the successful delivery of quality and regulatory strategy and operational performance for the Maryland campus.-- The Vice President, Quality is responsible for establishing and staffing the Quality Unit to ensure the organizational structure, talent, bench strength, and staffing is effective in delivering the expected outcomes, in the right way, for SQDC and strategic growth plans. This position reports directly to the Senior Vice President of Quality & Regulatory Affairs and will have strong working relationships with VP General Manager Maryland and other Site Leadership team members.-- Working with and leveraging the entire Global Catalent network, the position executes on growth strategies, leading quality-related aspects of the transition into commercial manufacturing and delivers on the expected quality culture for the manufacturing sites.----The VP of Quality is a key member of the BioProduct leadership team, responsible for promoting a Patient First culture and ensuring quality standards across the campus. They oversee Site Quality Directors/Senior Directors, maintain customer relationships, and address performance issues. The VP of Quality holds ultimate responsibility for site quality, compliance, and operational performance, including regulatory inspections and deviations. They also manage the budget and sourcing of the Quality Unit to meet business requirements. As a member of the Catalent Senior Leadership Team, they provide impactful leadership.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

• Partner effectively with other functional leaders (Product Development, Operations, etc.) and Site General Manager to develop and maintain a meaningful and robust Quality and Patient First and Quality culture across all aspects of the business.
• Champion, through clear and visible advocacy, Catalent's Quality Management System (QMS), and ensure strong technical and leadership capability at all levels of the Quality organization.
• Responsibility for ensuring the site Quality leadership teams (150-400 HC) is staffed with high caliber Quality leaders and professionals, driving strong and effective performance culture at all levels across the sites, and creating a strong succession pipeline for key leadership roles.
• Define activity-based cost models and establish and execute a budget that is in-line with the requirements of the business to deliver on the testing, release and QMS commensurate with the needs of the business to operate effectively and efficiently.
• Ensure appropriate metrics and reporting/escalation processes are in place and being utilized to drive and improve required operational execution and performance levels and drive appropriate corrective actions planning when needed.
• Drive actions and remediation as required to meet the quality performance and standards sets for the site.
• Drive execution and outcomes on critical deviations provide clear direction and oversight including the review and approval of the deviations as well as effective CAPA plans
• Development of strong customer relationships, partnering with other Catalent leaders to establish outstanding performance and customer impact that acts as a true competitive differentiator.The Candidate
  • Bachelor's or Master's Degree in science, pharmacy or related discipline is required. MBA or PhD as educational background is an advantage
  • 10+ years' experience in biologics is a requirement. Experience in managing a multi-site quality function in Biologics or Vaccines is required. (minimum of 100+ quality employees overseen)
  • Knowledge of global cGMP regulations including FDA, EMA, ANVISA, and other Tier 1 regulatory agencies.
  • Proven critical thinking aptitude in a demanding and fast paced environment.
  • Possesses visionary leadership; ability to identify new trends in the quality and regulatory landscape, allowing Catalent to lead the industry.
  • Proven experience in driving substantial improvements of quality performance across a broad range of initiatives including development and recruitment of talent, process improvements, elimination of exceptions/SOP standardization.
  • Demonstrated success in executing multiple major quality initiatives (such as: implementation of IT systems, upgrading plant regulatory status, commissioning new plant operation, etc.).
  • Provides reliable / defendable interpretations of regulatory guidance for the customer and is capable of defending these positions to regulatory agencies.
  • 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.Pay The anticipated salary range for this position in Maryland is $265,000 - $365,000 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 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 ReimbursementCatalent 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 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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