Senior Director, Quality

Catalent • Kansas City, MO

8d • Onsite

About The Position

Senior Director, Quality Position Summary: 100% on-site 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. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects. The Sr Director of Quality leads the Quality unit at the Kansas City site - Pharma/Consumer Health (PCH) and also leads the Quality organization for the Kansas City campus which includes the BioAnalytical Laboratory as well as the KC Clinical packaging and supply operation. As part of Catalent’s matrix organization, this individual will also have oversight from the BioAnalytical and Clinical Supply (CSS) organization. The candidate is responsible for setting the strategic direction, properly staffing, and maintaining the Quality Management Systems (QMS) to assure the KC PCH site and the campus is compliant with regulatory (21 CFR Parts 4, 201, 211, and 820), Corporate, and customer requirements. They are responsible for establishing and maintaining the metrics, management review, and building a Patient First culture for the campus. The Sr Director of Quality for the campus is the most responsible person at the campus for Quality and works very closely with the General Managers (GMs) for each segment for Operations to carry out the strategic day to day objectives set by the business. The Sr Director of Quality is responsible to provide project guidance and support and work with customers to resolve quality concerns as appropriate in an expedited manner. The Sr Director of Quality is responsible for operational and compliance performance across regulatory authorities and markets while meetings expectations necessary to drive growth and customer satisfaction. The role will be responsible for building high performing teams and systems by addressing all current and future needs and building short and long-term quality plans for the site and campus. The Role: Set strategy and vision for Kansas City campus for Quality Operations, specifically the Quality vision, culture, and strategic imperatives for the Quality organization and deliver on all business objectives through strong alignment with General Managers and their vision for their site. Ensure a sustained state of compliance with a strong focus on Continuous Improvement (CI), finding flexible and compliant solutions for the business (strong risk management skills). Serve as the campus's primary contact (with both customers and regulatory agencies) for the site Quality Unit ensuring expectations are met consistently and at a high level. Ensure the campus meets requirements for drug and combination product manufacturing across product technologies including Clinical Supply, Biologics and Analytical Services. Develop and implement the campus Quality Plan by segment, Quality Unit objectives and related procedures and maintain an effective Quality Management System (QMS) across the campus that aligns with regulatory requirements/expectations. Monitor site compliance to FDA, EU and all other applicable requirements and ensure regulatory and customer audits are managed successfully and any responses submitted in a timely manner. Direct a team of Quality professionals. Provide development and disciplinary actions (as needed) to assure the department remains engaged and motivated. Part of the Site Leadership Team (and campus) representing the QRA function for the site, supporting site mission/strategy and prepare, approve, and manage Quality departmental budget. Approve or reject, starting materials, packaging materials, and intermediate, finished products, and to evaluate batch production records. Ensure that all necessary QC testing is performed on manufactured products supporting and meeting business objectives and on-time deliveries. Ensure Quality approval of specifications, sampling instructions, test methods and other Quality Control procedures. Review and approve Site Annual Product Reviews and ensure that required validation activities are completed. Responsible for ensuring environmental monitoring and control of the manufacturing environment and plant hygiene. Ensure the proper designation and monitoring of storage conditions for materials and products. Actively participate in ensuring business measures/metrics are met (e.g. Customer service) Ensure that Document Control activities are compliant with FDA, EU and other applicable requirements and that controlled documents are maintained in an orderly manner to allow rapid retrieval when required. Other duties as assigned

Requirements

• Bachelor of Science required; MS preferred in Quality, Regulatory Affairs, Pharmacy, Chemistry or Biology and experience leading Quality Operations at a manufacturing site operation for 5+ years (e.g. Quality Operations, QC Operations, Manufacturing) is required.
• 10+ years’ experience in pharmaceutical or medical device industry with increasing levels of responsibility and leadership in quality assurance, compliance and quality control.
• Experience in the development of innovative and action-oriented quality programs are critical.
• Strong understanding of the functional areas of manufacturing, sourcing, materials management, quality assurance and control, microbiology and laboratory across manufacturing disciplines and segments (Commercial, Clinical, BioA)
• Must have a demonstrable record of implementing and maintaining a total quality system; laying out a strategic plan and overseeing the tactical implementation, driving improved operational and quality metrics.
• Proven ability to lead a large, multi-level/multi-shift organization (e.g. 50+ employees) effectively.
• Effective and demonstrated risk management skills, ability to be assess risk with a Patient First mindset.
• Knowledge of cGMP, ICH, and other non-US regulations / guidelines; demonstrated experience applying them to both cGMP manufacturing and/or QC lab environments.
• Ability to organize time for multiple tasks (major projects and daily functions) and deliver tasks on time.
• Effective written/verbal communication skills, organizational skill and ability to deliver formal presentations to co-workers or customers.

Nice To Haves

• Experience with Biologics / sterile drug product manufacturing is strongly preferred.
• 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

Responsibilities

• Set strategy and vision for Kansas City campus for Quality Operations, specifically the Quality vision, culture, and strategic imperatives for the Quality organization and deliver on all business objectives through strong alignment with General Managers and their vision for their site.
• Ensure a sustained state of compliance with a strong focus on Continuous Improvement (CI), finding flexible and compliant solutions for the business (strong risk management skills).
• Serve as the campus's primary contact (with both customers and regulatory agencies) for the site Quality Unit ensuring expectations are met consistently and at a high level.
• Ensure the campus meets requirements for drug and combination product manufacturing across product technologies including Clinical Supply, Biologics and Analytical Services.
• Develop and implement the campus Quality Plan by segment, Quality Unit objectives and related procedures and maintain an effective Quality Management System (QMS) across the campus that aligns with regulatory requirements/expectations.
• Monitor site compliance to FDA, EU and all other applicable requirements and ensure regulatory and customer audits are managed successfully and any responses submitted in a timely manner.
• Direct a team of Quality professionals. Provide development and disciplinary actions (as needed) to assure the department remains engaged and motivated.
• Part of the Site Leadership Team (and campus) representing the QRA function for the site, supporting site mission/strategy and prepare, approve, and manage Quality departmental budget.
• Approve or reject, starting materials, packaging materials, and intermediate, finished products, and to evaluate batch production records.
• Ensure that all necessary QC testing is performed on manufactured products supporting and meeting business objectives and on-time deliveries.
• Ensure Quality approval of specifications, sampling instructions, test methods and other Quality Control procedures.
• Review and approve Site Annual Product Reviews and ensure that required validation activities are completed.
• Responsible for ensuring environmental monitoring and control of the manufacturing environment and plant hygiene.
• Ensure the proper designation and monitoring of storage conditions for materials and products.
• Actively participate in ensuring business measures/metrics are met (e.g. Customer service)
• Ensure that Document Control activities are compliant with FDA, EU and other applicable requirements and that controlled documents are maintained in an orderly manner to allow rapid retrieval when required.
• Other duties as assigned

Benefits

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Dynamic, fast-paced work environment.
• Community engagement and green initiatives
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement

What This Job Offers

• Job Type: Full-time
• Career Level: Director