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Catalent Pharma Solutions Manager, Quality 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 (http://www.catalent.com/index.php/about-us/Catalent-Careers2)

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture.

Position Summary

The Manager, Quality Systems is responsible for the development, implementation, maintenance, and management of the site Quality Management System (QMS). Systems include GMP documentation management including administration of Standard Operating Procedures, GMP document archival, deviation and nonconformance, corrective and change management, quality metrics reporting, GMP training management and support of regulatory audits.

The Role

  • Management of personnel. Identify staffing requirements to meet current needs. Assist in Management responsibilities to include professional development, performance appraisals, employee counseling for direct reports, support of second tier management decisions and responsible for recommendation of courses of action on all management and human resources’ matters, including salary administration, transfers, hiring, terminations and position description preparations.

  • Provide leadership in support for all Quality System responsibilities. Write or approve site Quality Systems Standard Operating Procedures and associated forms and work instructions.

  • Management of the site monthly Quality Management Review meeting. Facilitate creation of the presentation materials to include the Key Performance indicators, the meeting agenda and attendance, and to orchestrate the material presentation.

  • Active participation in Regulatory Agency inspection pre-planning and inspection support.

  • Facilitate and support the weekly and monthly Quality metrics, reported to Corporate and Site management.

  • Facilitate the compliance with the Global Quality Standards. Organize and facilitate the draft Corporate Policy and Standard cross-functional reviews and provide site feedback to the global team.

  • Management of site procedure alignment with issued Corporate Policies and Standards within the corporate assigned timeline. Assign responsibilities to site personnel for the review impact and revision of site procedures for newly issued Global Policies.

  • Promote, implement and maintain site quality initiatives of processes and programs, assess compliance with regulations, Corporate Policies and Standards, site Standard Operating Procedures and client requirements.

The Candidate

Education or Equivalent:

  • Minimum Bachelor’s degree required with majors in Scientific discipline preferred, with at least 8+ years of related scientific or quality assurance (QA) experience.

Experience:

  • 8+ years of Scientific or Quality Assurance experience in a cGMP pharmaceutical manufacturing, packaging and/or analytical environment

Knowledge/Skills Requirements:

  • Two or more years of supervisory / leadership experience required

  • Clear understanding of cGMPs

  • Open and clear communication with direct reports; Communicates clearly with internal and external clients, both verbal and written.

  • Listens carefully to others and responds appropriately.

  • Demonstrates flexibility in organizing work and priorities.

  • Good organizational skills relating to management of associates daily activities.

  • Good problem-solving skills and decision-making skills to identify and solve work related issues.

Catalent’s standard leadership competencies

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

Position Benefits

  • Medical, Dental, Vision and 401K are all offered from day one of employment

  • 19 days of paid time off annually

  • Potential for career growth within an expanding team

  • Defined career path and annual performance review and feedback process

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 (https://catalent.wd1.myworkdayjobs.com/External) 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 (https://www.youtube.com/playlist?list=PLuUGqEwwnH7hBwFlrsfSOH_raQHu4hOBK) .

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