Site Name:GSK HQ
Posted Date:Sep 10 2024
Inspection Readiness Senior Director
The role can be located anywhere in the US, Europe or UK
We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 2.3 billion packs of medicines and doses of vaccines in 2023.
We continue to modernise, so we can launch even more new products at speed whilst continuing to deliver across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and 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.
Job purpose:
The primary purpose of this job is to create inspection readiness strategy and deploy the ambition to the GSK network. This person will ensure the GSK are aligned or ahead of the evolving regulatory inspection trends and expectations.
Key responsibilities:
- Accountable for setting the strategic direction and management of the Regulatory Inspection Compliance team who are engaged in assisting GSK sites with inspection readiness, including providing support pre-, during, and post-inspection
- Preparation of clear and objective reports to ensure that senior management and key stakeholders are apprised of any inspection readiness risk prior to an inspection to allow for appropriate corrective action plans to be implemented in a timely manner
- Mobilization of company experts to assist investigating and resolving inspection readiness gaps prior, during, and post the inspection
- GSK US FDA contact for assisting FDA in scheduling of International US FDA inspections
- Provide support, as necessary, in the Inspection Room during international FDA inspections
- Drive development of robust strategy for responding to any regulatory findings/observations and provide oversight and assistance during the regulatory response drafting process
- Manage the interface with key stakeholders including Site Directors and Site Quality Directors, and regional functions where appropriate.
- Develop inspection readiness capability at highly regulated sites through proactive knowledge sharing and collaboration
- Promote excellence and continuous improvement associated with inspection readiness best practice and processes
- Training and coaching of site SME's in preparation for external inspections to enable the best outcome possible for each site
- Owner of QMS policies and processes associated with Inspection Readiness
- Accountable for leading the Inspection Readiness Community of Practice
- Accountable for timely and effective sharing of key learnings and findings/observations from significant Regulatory Inspections are shared across GSK
- Responsible for the generation and monitoring of the Regulatory Inspection Compliance team budget
- Accountable for motivating the Regulatory Inspection Compliance team, keeping the team focus and promoting development within the team to ensure the right future ready capabilities and succession plans
Basic Qualifications:
- BA/BS degree or equivalent in experience (Chemistry, pharmacy, biological sciences, science related)
- Detailed knowledge of world-wide cGMPs, associated regulatory guidances and expectations and Quality Management Systems for pharmaceuticals, APIs, biopharmaceuticals, medical devices, and steriles
- Minimum 10 years' experience leading a team accountable for the conduct of GMP inspections on behalf of a major regulatory authority (e.g., US FDA, UK MHRA, EMA) and/or a team accountable for the inspection readiness of a research-based pharmaceutical company manufacturing pharmaceuticals, APIs, biopharmaceuticals, medical devices, and steriles
- GMP inspector experience with a " major regulatory authority " such as FDA but could also be MHRA (the UK regulator), HPRA (the Irish regulator), EMA (the EU regulator, etc)
- Proven track record of leadership and people management with demonstrated ability to work with and influence stakeholders at levels, including senior most management
- Highly proficient English verbal and written communications skills to ensure effective relay of issues, risks, objectives and opportunities both vertically and horizontally through the organization so that these are well understood by all parties and effective action plans can be put in place.
- Demonstrated ability to function effectively in a matrix organization, across multiple cultural and geographical boundaries.
- Expert knowledge of the existing and emerging regulatory environments in which GSK operates with a proven track record of proactively identifying regulatory inspection risks within those environments
- Demonstrated proficiency in the application and use of data analytics to predict and efficiently identify regulatory inspection readiness risks
- Broad based familiarity with Primary, Secondary manufacturing, and Biopharmaceuticals, sterile manufacturing
LI-GSK
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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