Section Head, QMS and Compliance
Section Head, QMS and Compliance
Apply locations: Swindon, United Kingdom Time type: Full time Posted on: Posted 2 Days Ago Time left to apply: End Date: January 28, 2025 (11 days left to apply) Job requisition id: 0086820 Catalent is currently recruiting for a Section Head, QMS and Compliance to join our Swindon site. The Section head is responsible for providing leadership for the individuals within the section and support at Catalent's Swindon site in Quality Management Systems and Compliance. Reporting to the Quality Manager, QMS & Compliance, with responsibility for the management and development of the individuals within the section, including performance reviews, annual appraisals, development, and succession planning. The Role: Ensure adherence to the standards of quality ruled by current cGMPs and the Company's Quality Policies and site Standard Operating Procedures. Complete compliance aspects of controlled substances reporting in accordance with Home Office requirements. Ensure that all QMS documentation is kept current, ensuring alignment with corporate policies and changes in regulatory requirements. Continually review and recommend improvements to QMS processes to increase process efficiency and effectiveness. Author/compile QMS metrics; providing summary data to site management/customers as required to support the site Quality Management Review process. Review metrics on the performance of the QMS and identify and implement changes required based on that data. Represent QMS as a contact for internal/external customers (via email, phone, teleconferences, face to face) demonstrating customer focus, negotiation skills, and flexibility. Maintain close dialogue with Operations, QC, Validation, and Engineering, ensuring that any issues of quality are resolved in a timely fashion. Support the Quality Manager, QMS & Compliance in the supervision of the QMS Team, including performance management and supporting staff in attaining their personal development goals. Organize the team in the management of the process for all key quality systems including but not limited to Deviations, Complaints, Change Controls, Suppliers, Annual Product Reviews, Actions, Training, Document Control, and Audits. Completion of regulatory affairs activities, including preparation and maintenance for DMFs and responding to regulatory inquiries from customers and regulatory agencies. Maintain personal and communal office areas in line with 5S principles. Deputise for the manager and act as departmental representative as required. Participate in Regulatory Inspections, customer audits, and internal audits as required. Ensure that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with Catalent values. The Candidate: Experience managing people. Report writing/reviewing experience. Knowledge of QMS & Compliance. Previous experience working within a GMP/Pharmaceutical company. 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. Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law. 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. 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. About Us
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! 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!
#J-18808-Ljbffr
Apply locations: Swindon, United Kingdom Time type: Full time Posted on: Posted 2 Days Ago Time left to apply: End Date: January 28, 2025 (11 days left to apply) Job requisition id: 0086820 Catalent is currently recruiting for a Section Head, QMS and Compliance to join our Swindon site. The Section head is responsible for providing leadership for the individuals within the section and support at Catalent's Swindon site in Quality Management Systems and Compliance. Reporting to the Quality Manager, QMS & Compliance, with responsibility for the management and development of the individuals within the section, including performance reviews, annual appraisals, development, and succession planning. The Role: Ensure adherence to the standards of quality ruled by current cGMPs and the Company's Quality Policies and site Standard Operating Procedures. Complete compliance aspects of controlled substances reporting in accordance with Home Office requirements. Ensure that all QMS documentation is kept current, ensuring alignment with corporate policies and changes in regulatory requirements. Continually review and recommend improvements to QMS processes to increase process efficiency and effectiveness. Author/compile QMS metrics; providing summary data to site management/customers as required to support the site Quality Management Review process. Review metrics on the performance of the QMS and identify and implement changes required based on that data. Represent QMS as a contact for internal/external customers (via email, phone, teleconferences, face to face) demonstrating customer focus, negotiation skills, and flexibility. Maintain close dialogue with Operations, QC, Validation, and Engineering, ensuring that any issues of quality are resolved in a timely fashion. Support the Quality Manager, QMS & Compliance in the supervision of the QMS Team, including performance management and supporting staff in attaining their personal development goals. Organize the team in the management of the process for all key quality systems including but not limited to Deviations, Complaints, Change Controls, Suppliers, Annual Product Reviews, Actions, Training, Document Control, and Audits. Completion of regulatory affairs activities, including preparation and maintenance for DMFs and responding to regulatory inquiries from customers and regulatory agencies. Maintain personal and communal office areas in line with 5S principles. Deputise for the manager and act as departmental representative as required. Participate in Regulatory Inspections, customer audits, and internal audits as required. Ensure that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with Catalent values. The Candidate: Experience managing people. Report writing/reviewing experience. Knowledge of QMS & Compliance. Previous experience working within a GMP/Pharmaceutical company. 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. Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law. 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. 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. About Us
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! 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!
#J-18808-Ljbffr
