Catalent Pharma Solutions

IT Manager, Quality Systems

Position Summary:

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

The IT Manager, Quality Systems has a primary focus on major applications that are deployed globally for Catalent worldwide. These systems include but are not limited to the tools, applications, and /or SaaS deployments for Electronic Document Management Systems (EDMS). The focus of the role is to continually explore opportunities for greater efficiencies through process improvements, standardized utilization, increased user adoption and satisfaction, and robust data integrity and compliance that meets or exceeds the expectations of Catalent’s Quality Standards. These efficiencies may occur in the form of global business process design, governance, strategic short term and long-term planning, future state roadmaps, M&A assessments, integrations, enhancements with continued compliance through change management.

The IT Manager, Quality Systems will have functional oversight and will touch all global quality systems across the Catalent network. This manager will act as a liaison with all levels and functions of the Catalent organization to maintain alignment of business system fit, form and function with operational objectives. This role must apply business process knowledge on a global scale, be able to lead global cross function teams, and possess enough technical expertise to accurately anticipate and recommend business process design elements and improvements.

The Role:

• 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 perform strategic planning, develop future state roadmaps, and assess impact of integrations through M&A activities

• Ability to work directly with the global business users to collect business requirements, define new or existing business processes and to translate those into user requirements

• Maintains knowledge of latest technology and business trends via attendance in outside seminars, defined training plans, and reviewing best practice literature and related materials

• In conjunction with SME’s, Quality Assurance, IT, CS Validation and Training ensure overall application compliance as a GXP application

• Work directly with the business community and colleagues within IT to provide guidance in areas of system support, application control and management

• 10% travel expectations (domestic & international)

• Other duties as assigned

The Candidate:

• High School diploma, required - Bachelor’s degree in Engineering, Computer Science, or a Life Science related degree, preferred

• 6+ years of hands-on application knowledge (as a user, business related or technical) for Electronic Document Management Systems

• 6+ years of business operational or support experience in a GMP organization

• 2+ years personnel management experience, preferred

• Possess experience with OpenText Documentum specifically the Life Sciences modules, preferred

• Experience with a full-scale implementation and life cycle management of a GxP application

• Skilled in writing requirement documents, reviewing technical specifications with detail explanations of completed design

• Experience with computerized systems validation, GXP assessments, and/or change management

• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds

• (PEOPLE LEADER ROLES) Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience

Why You Should Join Catalent:

• Several Employee Resource Groups focusing on D&I

• Potential for career growth within an expanding team

• Diverse, inclusive culture

• 152 hours of PTO + 8 Paid Holidays

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 (https://careers.catalent.com/us/en) 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.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .