Job Information
GlaxoSmithKline LLC Regulatory Inspection Compliance Director in Collegeville, Pennsylvania
Reference #: 399027 Site Name: GSK HQ, Upper Merion, Upper Providence Posted Date: Jun 24 2024
Location: GSK HQ (London) Other locations can be envisaged: US/UK/EU Job Purpose The primary purpose of this job is to assist GSK manufacturing sites in highly regulated markets to be inspection ready every day via consultancy and assessment. This role is responsible for working with sites to apply processes associated with inspection readiness and to assist them during GMP inspections by major regulatory authorities (e.g., US FDA, UK MHRA, EMA, Irish HPRA, China FDA) and, as needed, following regulatory authority inspections to assist in the preparation of responses to any findings from the authorities. Key Responsibilities:
Using a risk-based approach, assisting sites with their inspection readiness but conducting pre-inspection readiness activities, incluidng pre-inspection assessments, mock inspections, review of presentations on hot topics and coaching of fronters likely to interact with the regulatory inspectors during the inspection.
Preparation of clear and objective assessment reports to inform senior management of any inspection readiness risks and to create the opportunity to implement appropriate corrective action plans to address any such risks.
During inspections, provide support (e.g. Subject Matter Expert coaching, Control Room and Inspection Room Support)
Post inspection, actively participate in the response writing process (if the inspecting authority issues findings), create and circulate assessments regarding the implications, if any, of inspection findings for other sites in the network and, where conducted, participate in after action reviews.
Verify CAPA completion for findings from key regulatory inspections in advance of the next inspection by the same regulatory authority.
Propose updates to GSK's global Quality Management System and or local site SOPs based upon gaps in inspection readiness
Expand knowledge base at highly regulated sites through proactive knowledge sharing and collaboration.
Promote excellence and continuous improvement associated with inspection readiness best practice and processes.
Participation in the Inspection Readiness Community of PracticeWhy You? Knowledge/ Education / Experience Required Educational Background Minimum Level of Education:
BA/BS degree or equivalent in experience Area of Specialisation:
Chemistry, pharmacy, biological sciences, chemical engineering or science related Preferred Level of Education:
BA/BS or Master Degree
Minimum Level of Job-Related Experience
Good knowledge of world-wide cGMPs, regulatory requirements, standards and Quality Management Systems for pharmaceuticals, APIs, biopharmaceuticals, medical devices, steriles. Minimum 10 years experience preferred.
Proficiency and preferably a minimum of 10 years experience in identifying regulatory inspection risks.
Broad based familiarity with primary, secondary manufacturing, and sterile manufacturing.
Good knowledge of the pharmaceutical industry current best practice in analytical and manufacturing technologies, engineering practices, validation and cGMP compliance
Understanding of and experience in following corporate governance processes Other Job-Related Requirements
Ability and willingness to travel at short notice
Flexibility at all times
Up to 50% travel over the course of each year
When applying for this role, please download your CV in English + a cover letter to describe how you meet the competencies for this role.
Closing Date for Applications - July 15th Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and C will be used to assess your application.
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