Group Leader, Compliance

Catalent

Kansas City,MO  

2019-12-10 2020-01-09
compliance administration pharma

At Catalent, we recognize talent is our most important asset. Propelled by the passion to excel, we are committed to attracting, developing, and retaining talented and dedicated professionals who can help us deliver on our promise of more products, better treatments, reliably supplied.

From helping our customers produce world-class pharmaceutical products to identifying future technologies that will improve drug delivery, we achieve our amazing breakthroughs and innovations because of our talent!



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











The Group Leader, Compliance supports the state of regulatory compliance at the Catalent Kansas City, MO site through the Internal Audit, Supplier Quality Management, State licensing programs and other regulatory compliance issues and actions.







The Role



Specific Duties and Responsibilities:



Internal Audit:





+ Perform internal audits of GMP departments and related quality systems in accordance with site audit schedule and applicable procedures using the TrackWise Internal Audit module.



+ Remanagement.



+ Walk through program.









Supplier Management:





+ Perform external and paper audits and risk assessments of GMP suppliers and contractors in support of Supplier Management Program and in accordance with site schedule and applicable SOPs using the TrackWise Supplier Module.



+ Supplier Quality Agreements.



+ Material specific items including purchase specifications, elemental impurity evaluations and risk assessments.



+ Material Review Board chair.









State Licensing:





+ Support the completion and review of initial and renewal state licensing applications including VAWD and supplemental information to assure the site is appropriately licensed for the services KCM provides.









Additional Duties:





+ Provide professional development, performance appraisals, and employee counselling for direct reports. Manage staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level.



+ Responsible for the training of personnel who execute internal audits, supplier management and state licensing related activities.



+ Ensure that site procedures related to supplier quality management, internal audit and state licensing programs are aligned with global policies and applicable regulatory requirements.



+ Support other activities within the quality department, which may include providing compliance metrics for site and corporate management, supporting regulatory inspections, client audits, commercial data reports, compendial review board and other quality or regulatory activities as needed.









The Candidate



Education or Equivalent:





+ BS/BA in related field along with 3+ years of scientific or quality assurance experience. DEA or controlled substance experience a plus.









Knowledge/Skills Requirements:





+ Must exhibit and apply a strong understanding of cGMP, FDA, and other regulatory guidelines.



+ Communicates clearly with internal and external clients, both verbal and written. Strong technical writing skills.



+ Listens carefully to others and responds appropriately. Cooperates with co-workers, team player. Willingness to contribute to team activities.



+ Demonstrates flexibility in organizing work and priorities. Good organizational skills relating to management of associates daily activities.



+ Adequate problem-solving skills and decision-making skills to identify and solve work related issues. Experienced in a deadline driven environment.



+ Able to assess and mitigate risk as it relates to vendor impact at the site.









Physical Requirements:





+ Must be able to travel (approximately 15% per year).









We will identify candidates based on the following:





+ Leads with Integrity and Respect



+ Delivers Results



+ Demonstrates Business Acumen



+ Fosters Collaboration and Teamwork



+ Champions Change



+ Engages and Inspires



+ Coaches and Develops









Position Benefits:





+ Join a high growth and fast paced organization with a people focused culture



+ Global exposure, defined career path and annual performance review and feedback process



+ Competitive PTO and benefits including Medical, Dental, Vision and 401K













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.







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.





Paragon Gene Therapy, a unit of Catalent Biologics, in Baltimore, Maryland is a leading viral vector development and manufacturing partner in the rapidly expanding gene therapy market. To browse career opportunities in Maryland, click here.





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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