What are the responsibilities and job description for the Director of Quality position at Catalent?
Director, Quality
Position Summary:
Reporting to the Vice President Quality, Consumer Health and as a member of the Site Leadership Team this position is accountable for the direct management and guidance in the Quality and cGMP aspects of the organization. The individual will act as the Leader of Food Safety, Quality and Regulatory activities in the manufacturing site and will be accountable for maintaining the highest standard of Dietary Supplement Manufacturing, Food Safety, Food Quality and Food Security. The Director, Quality will ensure regulatory compliance with all applicable Federal, State, and Local regulations and compliance to customer and internal product specifications.
The Director, Quality will work closely with the SLT, their direct reports and federal regulators in the development, roll-out and management of corporate policies through compliance needs and current Good Manufacturing Practice (cGMP) and Food Safety guidelines. They will also ensure through their oversight of their team, that site-specific quality systems and procedures for conducting investigations, generating site and corporate quality metrics are established and followed. It is through their personal and team’s efforts, that both internal customers and external regulators will view the Catalent Quality Systems and team positively.
The Role:
The essential functions of this position include, but are not necessarily limited to, those specifically identified in this description. The position and its essential functions may change over time and these changes may not necessarily be reflected in the position description. The Company may, at its sole discretion, add to, change, or expand the essential or marginal functions of this position.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
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.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
Position Summary:
- 100% on-site
Reporting to the Vice President Quality, Consumer Health and as a member of the Site Leadership Team this position is accountable for the direct management and guidance in the Quality and cGMP aspects of the organization. The individual will act as the Leader of Food Safety, Quality and Regulatory activities in the manufacturing site and will be accountable for maintaining the highest standard of Dietary Supplement Manufacturing, Food Safety, Food Quality and Food Security. The Director, Quality will ensure regulatory compliance with all applicable Federal, State, and Local regulations and compliance to customer and internal product specifications.
The Director, Quality will work closely with the SLT, their direct reports and federal regulators in the development, roll-out and management of corporate policies through compliance needs and current Good Manufacturing Practice (cGMP) and Food Safety guidelines. They will also ensure through their oversight of their team, that site-specific quality systems and procedures for conducting investigations, generating site and corporate quality metrics are established and followed. It is through their personal and team’s efforts, that both internal customers and external regulators will view the Catalent Quality Systems and team positively.
The Role:
The essential functions of this position include, but are not necessarily limited to, those specifically identified in this description. The position and its essential functions may change over time and these changes may not necessarily be reflected in the position description. The Company may, at its sole discretion, add to, change, or expand the essential or marginal functions of this position.
- Responsible for ensuring that systems are in place to support compliance with Dietary Supplement cGMP requirements for the Catalent Wellness facility, processes and people for the markets in which its products are sold.
- Food Safety and Quality Team responsibility: developing, validating, verifying and maintaining Food Safety Plans and Pre-requisite programs.
- Direct all functional and operational aspects of the Quality Assurance program to ensure compliance with all appropriate regulations and standards. Supervise, provide guidance and leadership to plant Quality organization and development of the same.
- Lead client, third-party, and FDA quality assurance audits along with senior management.
- Develop and refine plant measurement techniques, control plan and corrective action activities. Liaise with various departments to modify standard operating procedures, and create new ones as needed.
- Review and ensure compliance with plant GMP’s, HACCP, sanitation and pest control procedures and standards.
- Ensure internal compliance assessments of the site are appropriately managed and that responses to resolve deficiencies are provided and communicated in a timely manner.
- Execute against company established Key Performance Indicators for Quality in collaboration with Operations.
- Monitor the Sanitation Programs to ensure compliance to Food Safety guidelines and the maintenance of Sanitary State of the facility and its equipment.
- Accountable for execution of all Quality, cGMP, and Food Safety training for the site and compliance of the plant population to the same.
- Development of relevant and plant specific Strategies and Objectives for themselves and their team members; including organizational succession planning. Management of Plant Quality budget and development of the same.
- Final decision making at the site regarding product quality and for product disposition.
- Other duties as assigned
- Bachelor’s degree in Food Safety, Microbiology, Chemistry, Food Science, Engineering, or other science related field. Knowledge of the industry's regulatory environment, specifically with 21 CFR 111 and 117.
- 7 plus years of progressive Quality experience within the dietary supplement and/or food industry, with at least 5 years in a management leadership position in a manufacturing environment.
- GFSI, HACCP and PCQI trained; NSF, SQF and UL certification experience preferred.
- Direct experience in the development and execution of Quality System, Food Safety and Sanitation programs.
- Demonstrated Investigation, Root Cause Analysis, and Corrective Action capabilities.
- Ability to prioritize and follow-through to achieve results and meet deadlines. Experienced, energetic, and innovative with an ability to embrace the entrepreneurship of a startup operation.
- Strong foundation in interpersonal communication concepts, specifically, written, oral, presentation, listening, and facilitation skills. Experience in collaborating with and leading cross-functional teams commonly found in a manufacturing organization.
- Proficiency in Excel, Word, PowerPoint and other similar computer applications
- 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.
- Potential for career growth on an expanding team
- Abundance of cross-functional exposure to other areas within the organization
- Opportunity to work globally
- 152 hours of paid time off annually 8 paid holidays
- Day one benefits! Medical, dental, vision and 401K benefits effective on your first day
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
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.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.