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Catalent Pharma Solutions Manager, Quality Assurance, Enterprise Systems in Kansas City, Missouri

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

Job Title

The Quality Assurance Manager, Enterprise Systems

Position Summary

The Quality Assurance Manager, Enterprise Systems is the Quality Unit lead providing compliance oversight of IT infrastructure and enterprise systems deployed across the Catalent Business Units and sites. Key responsibilities include review and approval of IT system computer validation documentation, IT and CSV QMS policies and procedures and quality oversight of global IT compliance (e.g. Change Control, Periodic Reviews, Deviations, CAPAs). The Quality Assurance Manager, Enterprise Systems role will support internal site and vendor site audits and regulatory inspections as needed.

The Role (daily responsibilities)

  • Quality oversight of Computer Validation for IT systems including review and approval of central CSV documentation to ensure compliance and adherence to CSV policies and standards.

  • Ensures that deployed systems comply with all applicable GxP, legal, and fiduciary policies, practices and requirements.

  • Assess changes to computer systems and data integrity regulatory requirements and communicate requirements to central functions and sites.

  • Review and approve global IT change controls

  • Review and approve periodic reviews of central systems

  • Collaborate on the maintenance of global CSV policies, standards and procedures.

  • Other duties as required in support of Catalent Pharma Solutions; mentoring other individuals within the organization in compliance; participating in Assessments; facilitating and conducting training

The Candidate (requirements)

  • Bachelor’s Degree in Computer Science, Business Administration, or other Science related field.

  • 5+ years’ experience in a Quality or IT role supporting enterprise systems projects and teams in a global environment. 5+ years of leadership responsibility managing cross functional teams.

  • 5+ years’ experience in Quality Assurance

  • Pharmaceutical and/or life sciences experience including Computer System Validation, 21 CFR Part 11 and general GxP experience preferred.

  • Strong interpersonal, communication and problem-solving skills.

  • Travel of approximately 25%.

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

Position Benefits

  • Opportunity to work Remotely

  • Exposure to Catalent as a Global Organization

  • Opportunity to travel 25% of the time

  • 19 days of PTO

  • Competitive Medical & 401K benefits

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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