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Catalent Pharma Solutions Manager, Global EDMS 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

Manager, Global EDMS

Position Summary

The Manager, Global EDMS is the process owner for the development of global, harmonized processes for the enterprise EDMS system and the implementation and post-implementation support across the Catalent Business Units and sites. Key responsibilities include providing overall Quality function leadership for the global EDMS system and establishing and defining the user requirements for deployment of the solution to support all functions. The Manager, Global EDMS key focus is continual improvement to support the growth of the business, improve operating efficiencies and influence decisions regarding business process changes.

The Role (daily responsibilities)

  • Participates and assists in the development of IT strategy and roadmaps for the enterprise EDMS system in collaboration with business and IT.

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

  • Works closely with the functional leadership, site personnel and IT organizations to develop standardized global business processes.

  • Works within and across the network functions and BU Quality to define standard work practices and solutions where feasible.

  • Assures that User Requirement Specifications (URS) are established for the enterprise EDMS system to support local and enterprise-wide business processes. Supports vendor selection and quality audits.

  • Serves as the business process lead on the cross-functional implementation teams that are responsible for the configuration, testing, and validation of EDMS solutions along with system deployment activities.

  • Works with site leadership teams to mobilize site projects and ensure site readiness to accept global solutions.

  • Ensures effective training on the EDMS solutions is developed and deployed for internal and external stakeholders.

  • Coordinates the ongoing system support (w/ the various IT technical areas) and the global change management and change control.

  • Accountable for EDMS program delivery communications, organizational change management activities and project deliverables. Communicates on project related activities to the sponsor, operating committee, steering committee and other program stakeholders.

  • Leads and influences the analysis of available functionality of EDMS system, new business processes & operating models, and operational readiness assessment.

  • Assess current and future processes & requirements and assist the development of business cases that increase efficiency and compliance.

The Candidate (requirements)

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

  • 3+ years’ experience supporting EDMS (e.g., Documentum) projects. 2+ years of leadership responsibility managing cross functional teams s.

  • Strong interpersonal, communication and problem solving skills.

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

  • Strong team player and independent contributor with solid strategic thinking, creativity and analytical skills.

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

  • Ability to work remotely

  • Exposure to the global Catalent organization

  • Opportunity to work across multiple sites

  • Competitive Medical Benefits and 401K

  • 19 Days of PTO

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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