Business Introduction:
We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and product. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.
Position Summary:
This role leads a team of professionals acting as advisor, facilitator and team member regarding regulatory compliance and pertinent quality systems for all aspects of the manufacturing, testing, storage and distribution of pharmaceutical products. This position will provide guidance and training to new and existing employees and assist them with decision making. You will lead regulatory compliance activities across US operations. You will work with quality, manufacturing, and technical teams to ensure compliance with regulations and company standards. Your team values clear thinking, practical problem solving, and collaboration. You will have the chance to grow your skills, shape compliance practices, and make a measurable impact on patient safety and public health. Join us to unite science, technology and talent to get ahead of disease together.
Responsibilities:
This role will provide you the opportunity to lead key activities to progress your career. You will lead regulatory compliance programs and ensure alignment with US and global regulatory requirements. Support inspection readiness including responses to regulatory authority requests and audits. Manage regulatory risk assessments and drive corrective and preventive actions to closure. Collaborate with cross-functional teams to implement compliance plans and improve processes. Prepare clear reports and metrics for leadership on compliance status and improvement initiatives. Coach and influence colleagues to build a proactive compliance culture across the organization.
- Ensuring all proposed technical changes are properly assessed via the Change Control System, providing guidance to the impact on regulatory submissions, RIS (Regulatory Implementation Strategy) and using this information to assist change owners in the assessment of scope for the change.
- Ensures site representation in meetings requiring regulatory input and updates. (i.e. PTRT, CoPs, Change Control Panel,)
- Manage the implementation of registered commitments to ensure continuous compliance and success in global regulatory authority inspections (e.g. FDA).
- Coordinates efforts with GSK Regulatory Affairs, LOCs and other business departments to assure all mandatory licenses and registrations are kept current and in compliance with relevant health authority requirements.
- Oversee the management of Quality Agreements (QA and iQA) and Quality Agreement Product Requirements Specifications (QAPRS) for API’s supplied to Zebulon, US marketed products managed by Zebulon, products supplied by Zebulon and Secondary Contract Manufacture (SCM) products managed by Zebulon.
- Supervise employees related to the management of regulatory compliance and quality systems using established procedures and guidelines.
- Accountable for employee development and/or performance management through activities such as assignments and associated technical training programs. Coach direct reports with problem solving.
- Support Quality Compliance Director with succession planning, setting team objectives, implementation of new departmental strategies.
- Act as single point of accountability for site regulatory compliance. Create an environment where strategic decision making is encouraged in order to drive site regulatory compliance for all new and existing products.
- Manage the Periodic Product Review (PPR) Program for the Site.
Basic Qualifications:
We are seeking professionals with the following required skills and qualifications to help us achieve our goals.
- 8+ years' experience in cGMP environment, with 5+ years in regulatory affairs or a quality or regulatory compliance role with hands-on regulatory compliance experience in a regulated industry (pharmaceutical, biotech, or similar). Must have a minimum 2 years as a people leader.
- BS or BA in relevant technical discipline, including life sciences, engineering, regulatory affairs, or a related field, or equivalent experience. Sufficient technical depth or professional experience will be considered in lieu of technical degree.
- Demonstrated experience with GMP’s, FDA, MHRA, EMA and other regulatory agency requirements for pharmaceutical validation and operations, analytical and stability functions and compliance.
- Demonstrated experience with GMP’s, NIH Guidelines, FDA and other regulatory agency requirements preferred.
- Extensive working knowledge of GSK marketed products (US & International) with emphasis on Chemistry, Manufacturing and Controls (CMC).
- Demonstrated experience supporting regulatory inspections and audit activities. Strong knowledge of US regulatory requirements and good manufacturing practices.
Preferred Qualifications:
If you have the following characteristics, it would be a plus.
- Advanced degree in a relevant scientific or technical discipline.
- Good written communication, organizational, and computer skills. Able to prioritize and decide appropriate course of actions. Effective at implementing decisions.
- Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QC.
- Extensive working knowledge of GSK marketed products (US & International) with emphasis on Chemistry, Manufacturing and Controls (CMC).
- Good understanding and interpretation of Global regulations pertaining to the manufacture, holding, and distribution of human drug products.
- Good working knowledge of regulatory affairs, including submissions/supplements/variations and approved dossiers.
- Demonstrated experience supporting regulatory inspections and audit activities. Strong knowledge of US regulatory requirements and good manufacturing practices.
- Proven ability to lead cross-functional projects and influence stakeholders.
- Excellent written and verbal communication skills with attention to detail.
- Experience with global regulatory interactions and harmonization activities.
- Experience coaching teams and building compliance capability.
- Familiarity with quality management systems and trending tools.
- Experience writing regulatory submissions or formal responses to authorities.
- Prior experience in continuous improvement or operational excellence programs.
Work Arrangement:
This role is hybrid. You will be expected to work on-site regularly, with flexibility for remote work as agreed with your manager.
What you can expect from us:
You will join a team that values inclusion, clear communication, and practical action. We support learning and career development. We welcome different perspectives and want people who will help us do the right thing for patients, safely and reliably.
Ready to apply?
If this role fits your experience and ambitions, we encourage you to apply. Share a concise summary of how your background matches the basic qualifications and a short example of a compliance challenge you led. We look forward to hearing from you.
