Catalent · 5 hours ago
Senior Director, Quality
Kansas City, MO
Full-time
Onsite
Director/Executive
10+ years expCatalent is a global leader in drug development and delivery, and they are seeking a Senior Director of Quality to lead the Quality unit at their Kansas City facility. The role involves setting the strategic direction for Quality Operations, ensuring compliance with regulatory requirements, and building high-performing teams to meet business objectives.
BiotechnologyHealth CareManufacturingPharmaceutical
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
Qualification
Required
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 with Biologics / sterile drug product manufacturing is strongly preferred
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
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
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
Company
Catalent
Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions.
10001+ employees
H1B Sponsorship
Catalent has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2021-01-06Acquired
Leadership Team
Alessandro Maselli
President & Chief Executive Officer
Charles Lickfold
Senior Vice President, Chief Information Officer
Recent News
2026-01-22
Company data provided by crunchbase