Regional Director of Quality – EU Operations Biologics

工作内容

Job Description

Job Title: Regional Director of Quality – EU Biotherapeutics

Location: Switzerland, Belgium, France or Italy

Position Summary

The regional Director Quality, EU Biotherapeutics is accountable for ensuring the successful delivery of quality and regulatory strategy and operational excellence at Catalent EU Biologics facilities. This is accomplished through leading through others by building and maintaining strong relationship with BU VP of Operations, PD, Finance and other functional leads as well as the supporting Site Quality Heads and Site General Managers. The incumbent will have the necessary leadership and technical depth/background to provide technical guidance for the site deviations, projects, operational excellence, and act as the regional representation for customers in the region. In addition, the incumbent will provide leadership for significant projects including Due Diligence, site integrations and other regional projects as necessary. The position works with various functions across Catalent as a knowledgeable resource for regulatory compliance and participates in or leads targeted compliance improvement teams as needed.

The Role

• Work with Site Quality Directors and General Manager to translate and operationalize Quality, Regulatory and Compliance strategy into deliverable actions for individual sites while maintaining a robust "One Catalent" QMS.
• Partner effectively with other Quality and Functional leaders (Manufacturing, 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
• 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.
• Oversee and deliver on enterprise projects and IT systems supporting GxP activities.
• Perform due diligence and provide Quality and regulatory guidance to the larger team and suitability and fit. Provide and execute on integration activities for regional purchases
• Facilitate Quality Best Practice sharing across the Biologics Network and with the rest of Catalent.
• Participate in the weekly Biologics SQDC (Safety Quality Delivery and Cost) calls with the sites to make sure metrics are reported timely and consistently & coordinate the pre-work before the calls (specific topics of interest, etc.)
  

The Candidate

• Bachelor’s or master’s degree in science, pharmacy or related discipline is required. MBA or PhD as educational background is a plus.
• Extensive experience (10+ yrs) in aseptic operations, Biologics operations and large molecule analytics. Cell and Gene therapy experience a plus
• Proven experience in managing a regional quality function in Biologics or Vaccines
• 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.
• Knowledge of global cGMP regulations including FDA, EMA, ANVISA, and other Tier 1 regulatory agencies with a continuous improvement mind-set and disposition is critical.
• Leads through influence and able to leverage the matrix.
  

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.

Catalent. More products. Better treatments. Reliably supplied. ™
Visit www.catalent.com/careers to explore career opportunities.

C atalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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.