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Catalent Pharma Solutions Sr. Director - Site Quality Head, Biologics in Bloomington, Indiana

Job Description

Position Overview:

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here

Position Summary

Reporting directly to the Vice President of Quality, Biologics and with strong working relationship with the Site General Manager as well as SVP Quality, this key leadership position is accountable for ensuring the successful delivery of quality and regulatory strategy and operational performance at the Bloomington, IN facilities.

The focus will be on building talent bench strength at the site level, building quality capacity to meet expected demand increases, integrate into and leverage the entire Catalent network, execute on growth strategies, lead quality-related aspects of the transition into commercial manufacturing, and deliver on regulatory approval of the manufacturing site.

The Role

  • Partner effectively with other functional leaders (Manufacturing, Operations, etc.) and Site General Manager 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 Manager 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.

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.

  • Experience in managing a site quality function in Biologics or Vaccines is required.

  • 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.

  • Provides reliable / defendable interpretations of regulatory guidance for the customer and is capable of defending these positions to regulatory agencies.

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 www.catalent.com/careers to explore career opportunities.

Catalent 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.

Catalent = Catalyst + Talent

Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!

personal initiative. dynamic pace. meaningful work.

Catalent is the perfect place to grow your career if…

  • You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).

  • You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!

  • You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.

  • You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.

  • You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU!

  • See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here.

Catalent 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, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

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