Vice President, Quality Biologics - Europe

Job content

Position Summary

Reporting directly to the Senior Vice President of Quality & Regulatory Affairs and with strong working relationship with the VP Operations, Biologics EU this key leadership positions is accountable for ensuring the successful delivery of quality and regulatory strategy and operational performance across Europe (Sites Include: Brussels, Belgium; Limoges, France; Anagni, Italy; and Oxfordshire, UK). The initial focus will be on building talent bench strength at the site and divisional levels, building quality capacity to meet expected demand increases, integrate into and leverage the entire Catalent network, execute on growth strategies (to include future potential acquisitions and site expansions), lead quality-related aspects of the transition into commercial manufacturing, and deliver on regulatory approval of manufacturing sites.

The VP of Quality is a member of the European global leadership team and is expected to lead in a manner that promotes and drives a Patient First culture throughout the organization. The Vice President of Quality is directly responsible for the Site Quality Directors/Senior Directors under their responsibility and drives "One Catalent" quality standards across sites, ensuring that the systems necessary to produce products in conformance with good manufacturing practices and standards are implemented and followed. The Vice President of Quality is also responsible for establishing and maintaining positive customer relationships and providing direction to the customer and organization to address critical performance issues.

Ultimate responsibility of the quality, compliance and operational performance of the sites rests with the VP of Quality for the region. This includes but is not limited to working through regulatory inspections and responses, as required leading others through critical deviations and outcomes including working with customers on the disposition of product and/or other regulatory actions.

The VP Quality is a member of the Catalent Senior Leadership Team (SLT), and as such is expected to provide strong and impactful leadership commensurate with being a senior leader of the company.

The Role

• Partner effectively with other functional leaders (Product Development, Operations, etc.) and Site General Managers to develop and maintain a meaningful and robust 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.
• Work with Site Quality Directors and General Managers to translate and operationalize Quality, Regulatory and Compliance strategy in a way that is appropriate for individual sites while maintaining a robust "One Catalent" QMS.
• Responsibility for ensuring the site Quality leadership teams are 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.
• 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.
• Deliver on the annual goals and objectives established with and approved through the business unit.
• Demonstrate strong business and fiduciary responsibility in the management of their budgets, and broader business decision-making, acting as both functional and business leaders.
• Development of strong customer relationships, partnering with other Catalent leaders to establish outstanding performance and customer impact that acts as a true competitive differentiator.
• Evaluates existing processes and identifies improvement to enhance efficiency, consistency, and competitiveness within the market.
  
  

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
• Extensive experience (10+ years) in aseptic operations, Biologics operations and large molecule analytics.
• The role must be located Switzerland (preferred), Belgium, France, Italy, or the UK
• Ability to travel throughout the region and sites as needed / up to 50% travel
• Demonstrated business acumen and ability to manage through difficult discussions with clients.
• Experience in managing a multi-site quality function in Biologics or Vaccines is required.
• Ability to operate effectively in an environment with high levels of ambiguity.
• 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 experience of successfully leading a multi-site Quality leadership team, preferable in a matrix-style organization.
• Knowledge of global cGMP regulations including FDA, EMA, ANVISA, and other Tier 1 regulatory agencies.
• Demonstrated success in executing multiple major quality initiatives (such as: implementation of IT systems, upgrading plant regulatory status, commissioning new plant operation, etc.).
• Possesses strong customer orientation with a passion for excellence. Tenacity in achieving objectives and deadlines.
• Leads through influence – not an autocrat and able to leverage the matrix.
• Must possess significant learning agility and must be able to get to the heart of issues succinctly and propose ideas with conviction.
• Ability to deal with high levels of complexity, focusing on outcomes.
• Continuous improvement mind-set and disposition is critical.
• Provides reliable / defendable interpretations of regulatory guidance for the customer and is capable of defending these positions to regulatory agencies.
• Catalent Values and Competencies.
• Ability to effectively present information and respond to questions from Executive Leadership team.
• Ability to work effectively under pressure to meet deadlines.
  
  

Catalent’s standard leadership competencies that are used to interview and for Performance & Development:

• Leads with Integrity and Respect
• Delivers Results
• Demonstrates Business Acumen
• Fosters Collaboration and Teamwork
• Champions Change
• Engages and Inspires
• Coaches and Develops
  
  

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 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.

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