I. Position Overview:|
The position is responsible for developing, implementing and continually improving Catalent’s Quality systems and programs in a manner that complies with external regulatory requirements.
II. Specific Duties, Activities, and Responsibilities:
Develop, implement and communicate a clear strategic vision for quality to maximize employee focus and develop a competitive advantage. S/he will maintain the highest degree of product quality and quality systems, grounded by the ability and vision to anticipate and prevent regulatory problems. The successful candidate will bring an expert-level understanding of regulatory issues and the changing climate, along with a proven ability to maintain strong relationships with regulatory organizations and other industry contacts. This will enable the incumbent to anticipate changes in the regulatory climate, and redesign processes accordingly. It is crucial that this individual quickly gain the credibility and respect of his/her team, customers, and the senior executives of other functional areas within Catalent, particularly with operating leadership. This will require the ability to finesse the natural tension which exists between the twin needs of compliance and productivity.
Direct a team of approximately 125 department personnel and have overall responsibilities for lab operations, validation, regulatory and manufacturing quality assurance. Must have a demonstrated track record of talent management; building bench strength and setting clear objectives for performance and accountability. The position is based in Woodstock, Illinois, one of Catalent’s largest and most significant sites.
Responsible for the quality aspects associated with manufacturing, packaging, storage and release of all products produced at the Woodstock site. S/he is also responsible for compliance to global standards of cGMP.
Leads Quality Strategic Planning and Quality yearly objectives setting that meet compliance requirements and business needs.
Assures that systems are in place in all areas of technical operations to achieve compliance with cGMP regulations and corporate quality standards.
Oversees laboratory operations, responsible for testing/inspecting and releasing materials for use in product manufacturing and packaging and final product testing.
Oversees compliance operations, responsible for complaint evaluation, internal and external investigations, internal and external supplier auditing, batch audit and release, stability coordination/evaluation and product data trending, etc.
- Maintain effectiveness of the Quality System components relevant to this position.
- Other duties as assigned.
III. Position Requirements:
Education or Equivalent:
- B.S. degree in a technical field (i.e., chemistry, pharmaceutics, engineering)
- M.S. or Ph.D. preferred
Approximately 10-15 years experience in a similar organization with at least five of those years in a senior supervisory role, with the majority of this experience gained in an aseptic or sterile production environment.
Must have a demonstrable record of implementing and maintaining and total quality system; laying out a strategic plan and overseeing the tactical implementation, driving improved operational and quality metrics. This person will assure that systems are in place and that inter- and intradepartmental communications are such that “things be done only once – the right way.”
Successful development and implementation of a quality strategy for a manufacturing operations environment. Successful in implementing consistent standards.
Experience in facilitating FDA inspections.
Strong understanding of the functional areas of manufacturing, sourcing, materials management and quality control.
Strong knowledge base in microbiology, analytical chemistry, developmental chemistry or another life science.
Understanding of QA/QC GMPs and in interpreting and enforcing regulatory requirements.
Comprehensive knowledge of regulatory organizations and requirements – FDA, OSHA, environmental groups, as well as international regulatory agencies.
- A high energy level matched with enthusiasm is an important attitude within the organization and this quality is expected. Will set example for department through personal commitment and drive. Additionally, this individual must have the credibility to make effective presentations to scientific/clinical and FDA audiences.
- Critical Thinking - Able to work in uncharted areas. Capable of integrating large amounts of information to address complex issues. Challenges conventional wisdom when required. Intellectually aggressive with a strong end-product orientation.
- Interpersonal Skills - Able to quickly establish and maintain excellent interpersonal relationships within all levels of the organization. Creates team atmosphere with internal staff while achieving key objectives. Maintains positive, professional relationships with external contacts. He/She should be able to interface effectively with investigators as well as manufacturing staffs so that they will willingly accept this individual’s counsel and direction.
- Organizational Skills - Able to operate independently. Manages time well, follows through on commitments and pays attention to details. Able to work on several projects simultaneously.
- Maturity - Able to provide a good balance of risk taking and judgment. Is assertive and confident. Recognizes when help is needed because of lack of pertinent knowledge.
- Training/Mentoring Skills - Able to foster the professional development of subordinates through mentoring, and feedback on results. Willingly share personal knowledge and experience and is able to move decisively with performance problems. Able to assist in the recruitment of top talent, as required. He/She will not be only a trainer, developer, and supervisor but also a mentor who enjoys bringing individuals and teams to higher plateaus.
- Professional - Able to demonstrate unquestionable integrity, credibility and character. Has demonstrated high moral and ethical behavior.
- Demonstrated ability to read, write, and speak clear English.
- Ability to stand for up to 8 hours per day
- Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, talking, writing, listening
- Occasional climbing ladders/steps, walking up inclines and uneven terrain, reaching with hands and arms, stooping, kneeling, crouching, crawling, twisting, bending, handling, turning, balancing, carrying, grasping
- Occasional lifting and/or moving up to 30 pounds
- Performance driven
- Customer focused
- Collaborative and inclusive
Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 8,500 people, including over 1,000 scientists, at nearly 30 facilities across 5 continents and in Fiscal 2013 generated more than $1.8 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, visit
More products. Better treatments. Reliably supplied.™
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
. 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.
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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