Director, Quality Assurance, Enterprise Systems

Job Title: Director, Quality Assurance, Enterprise Systems

Job Location: Field

Computer Software Assurance oversees and ensures the validation is based upon the impact of the system on patient/customer safety or product quality. CSA involves critical thinking and risk management where we leverage the knowledge of the use of the system, and our knowledge of the business and processes. The riskier a system’s impact to patient safety or product quality, the more “assurance” required via testing and documentation. The opposite holds true then for indirect impact systems.

The Quality Assurance Director, Enterprise Systems is the Quality Unit leader providing compliance oversight of IT infrastructure and enterprise systems deployed across the Catalent Business Units and sites. Key responsibilities include developing global, harmonized processes to support implementation, leading enterprise system strategic initiatives, review and approval of global enterprise 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 role is key to data integrity initiatives, execution of internal site and vendor site audits and regulatory inspections preparation.

• Joint partnership to develop of IT strategy roadmap for IT infrastructure and enterprise systems with IT leadership
• Assist in facilitating governance boards, Centers of Excellence such as Data Integrity and Computer Software Assurance Centers of Excellence etc.
• Design/ build and conduct/oversee of training of Catalent personnel on CSV, Change Control, Data Integrity and on relevant Quality standards
• Prepare and conduct or assist/oversee Enterprise System / Vendor audits per established risk based strategy
• People management including cross functional talent- recruits talent (contract and/or full time) and builds a high performance team, mentors and coaches other individuals within the organization in compliance; participating in assessments; facilitating and conducting training
• Collaborate on the maintenance of global CSU policies, standards and procedures.
• Assess changes to computer systems and data integrity regulatory requirements and communicate requirements to central functions and sites.
• Develop a risk management strategy for DI controls and oversee the 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.
• Drives the quality and compliance of deployed systems with all applicable GxP, legal, and fiduciary policies, practices and requirements.
• Partner with Operations and IT organizations to develop standardized global business processes to ensure compliance with regulatory and quality requirements
• Oversee the review and approval of global IT change controls, and periodic reviews of central systems

Key Competencies

• Ability to manage other personnel, whether they are in-house permanent, temporary associates or consultants
• Global IT Quality systems knowledge and knowledge of CSV regulations and requirements
• Able to develop and foster a global presence by maintaining healthy relationships with the Quality team delegates at all sites in the network
• Ability to effectively present information, respond to questions from peers, management, and suppliers
• Familiarity with computer infrastructure, servers, workstations, operating systems.
• Lead and develop a high performing team that can collaborate with the business and functions to deliver on strategic initiatives.

Education or Equivalent Requirements:

• Bachelor’s degree in Computer Science, Business Administration, other Science related field
• Travel of approximately 25%.
• Pharmaceutical and/or life sciences experience including Computer System Validation, 21 CFR Part 11 and general GxP experience preferred.
• In lieu of Bachelor’s degree a minimum of 8 years of Quality or IT role supporting enterprise systems and 10 years total relevant experience will be considered.
• Strong interpersonal, communication and problem-solving skills.
• 8+ years’ experience in Quality Assurance

Knowledge/Skills Requirements:

• Strong interpersonal, communication and problem-solving skills.
• Strong organizational skills with good attention to detail

Physical Requirements:

• Travel of approximately 25%.

To perform this job successfully, an individual must be able to perform each duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This job description reflects the general duties of the job, but is not a detailed description of all duties which may be inherent to this position. Catalent may assign reasonably related additional duties to individual employees, consistent with company policy.

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 [email protected]. 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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