Regulatory Compliance Lead

GSK•Zebulon, NC

1d•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.