Product Quality Strategy Lead

Job description Site Name: UK - County Durham - Barnard Castle, UK - Hertfordshire - Ware, USA - Pennsylvania - King of Prussia, USA - Pennsylvania - Upper Providence Posted Date: Dec 2 2024 This role sits within the GSK Global Quality function (within the Pharmaceutical Supply Chain) and reports into the Senior Director – Product Quality Strategy.
Job purpose: This role is responsible for quality oversight of product(s) as they transition from clinical trial phase III (commit to) through commercial launch (and into the product life cycle).
The position provides quality over-sight and expertise as the product is prepared for commercialisation.
In delivering your role you will oversee and manage the Quality Strategy for New Products under late development (starting from phase III) to ensure that the overall Quality, Technical Development, Product Quality Risk, Compliance, and Regulatory considerations are integrated according to GSK Quality goals.
To achieve this you will work closely with Research and Development, MSAT, Global QC, CMC leaders and Manufacturing sites (including third-party partner organisations), as well as all relevant regulatory bodies.
Key Responsibilities (include): Drive the End-to-End Product Quality of commercial Vaccines and Medicines (for commercial advantage) focusing on proactive product, process, and analytical improvements.
Establish strategic partnerships with Technical experts (MSAT Molecular Steward, Site Quality Heads, QC Heads), Product Strategy team managers, GRA CMC leads, and RD CMC leads to ensure that Product Quality Strategy is embedded throughout development and commercialization efforts for successful launch, lifecycle management and continued marketing of Vaccines and/or Medicines.
Chair the Product Quality/CMC Quality Team to ensure alignment on Quality Strategy of the assigned product and ensure One Voice Quality at CMC technical/strategy meetings.
Also to represent all Quality Functions at the PTLT/PSLT with responsibility for defining the Product Quality Strategy (PQSt) for commercial Vaccines or Medicines.
Responsible for Product Quality elements of the RD CMC matrix teams and developing the overall product quality strategy, including Quality oversight of TRA/CPP/PCS, definition of release specification, stability and Shelf-life strategy.
Defines and adheres to CMC quality deliverables or milestones that will support NPI acceleration from the commit to Phase III to product launch.
Ensures quality management of transversal/global changes, deviations and CAPAs associated with the assigned product comply with cGMP standards, extending to product quality risk detection and overseeing actions/mitigation of the risk.
Communicating escalation of potential issues and risks to line manager and manage through appropriate governance forum.
Quality oversight of Product Quality Reviews (PQR) and Manufacturing Robustness Review Boards (MRRB) for the assigned asset.
Reviews dossiers/ files submitted to health authorities, as well as the approval of regulatory submissions (and support pre-approval inspection readiness).
Management/ oversight of post approval changes.
Provides functional expertise and guidance to their assigned asset(s), communicating project needs to quality functional areas (e.g., external quality, quality assurance, lot release).
Oversight of process validation, viral safety, sterility assurance and device controls for the aligned products.
Global remit:   Please note that in this role supports a global community, so flexibility on working hours will be required to attend meetings with colleagues and customer groups (to include USA and Europe time zones).
Location:  Although the role works from an above-site perspective we are ideally looking for applicants who can be based out of one of the following sites:  Barnard Castle (Durham, UK), Ware (Hertfordshire, UK), Upper Providence or Upper Merion (Pennsylvania, USA).
About You: This role is a great opportunity to be instrumental in driving GSK's quality strategy (in relation to its new products).
As this role is multi-faceted and includes liaising with a wide variety of stakeholders (including on-site production/operations teams and senior managers), you must be a motivated person who has strong experience of working in complex technical and/or manufacturing situations.
You will be resilient and calm under pressure, with strong people skills and a proven ability to influence people to achieve and drive performance.
You will have a strong continuous improvement mindset and be hands-on in your approach.
APPLICATION CLOSING DATE – Monday 16th of December 2024 (COB).
Basic Qualifications: Proven direct experience in the pharmaceutical manufacturing or R&D late phase clinical-trials.
Great understanding of the Quality and Regulatory requirement from Process Qualification to lifecycle management.
Relevant qualifications (eg; degree in Science, Pharmacy, Engineering or equivalent).
Strong and specific technical knowledge of GMP and CMC Quality standards required for clinical manufacture and release.
Benefits: GSK offers a range of benefits to its employees, which include, but are not limited to: Competitive base Salary Annual bonus based on company performance Opportunities to partake in on-the-job training courses Opportunities for support for professional development and chartership (accreditations and professional bodies) Access to healthcare and wellbeing programmes Employee recognition programmes If you would like to learn more about our company wide benefits and life at GSK we would suggest looking at our webpage Life at GSK | 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.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on ****** or 0808 234 4391.
Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels.
However, we have created a UK Recruitment FAQ guide.
Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive .
As you apply, we will ask you to share some personal information which is entirely voluntary.
We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions.
We would really appreciate it if you could take a few moments to complete it.
Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site.
All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK.
The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK.
In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.
GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment.
This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements.
For more information, please visit GSK's Transparency Reporting  For the Record site.