Remote Quality Lead
3 weeks ago
Site Name: UK - County Durham - Barnard Castle
The Global Manufacturing Science and Technology (MSAT) organisation is a network-focused function which provides strategic direction and technical / operational support to ensure that GSK Global Supply Chain(GSC) network, and site goals / objectives for life-saving medicines areachieved,through afocusedstrategy execution.
As the Biologics Drug Product Lead, you will be responsible for technical leadership for injectable drug products (both biologic and oligonucleotide) spanning new product introduction (NPI) to post-approval commercial supply across multiple manufacturing sites as appropriate while maintaining key relationships with the operational teams on manufacturing sites, particularly MSAT, Production, Engineering and Quality and also with R&D. The Biologics Drug Product Lead is responsible for technology transfer, process validation, supports regulatory filing activities, preparation for PAI and technical support through the product lifecycle including knowledge management.
We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programmes.
our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
Responsible for ensuring all aspects of Product Quality Lifecycle Management are in place and actively maintained for drug product: Technical Risk Assessment, Product Control Strategy, Stage 2 and Stage 3 (PPQ and CPV) Process Validation, Process Robustness Assessment, Leads cross functional improvement projects, and change implementation impact assessments on CQAs/CPPs. Ensures risks are identified and escalated as appropriate and mitigation plans are in place and agreed within appropriate quality systems e.g. Provides technical input to regulatory submissions for first file, post-approval submissions, annual reports, Periodic Product Reviews, and internal and external audits.
Responds to technical questions during regulatory submission and inspections. Principal point of contact for all aspects of current and previous knowledge on the product and performance, including critical quality attributes (CQAs) and critical process parameters (CPPs). BSc in Scientific Discipline (Scientific, Engineering, Technical)
Experienced in technology transfer, with an understanding of the product development process, regulatory requirements for biopharmaceutical production.
Must have excellent verbal and written communication skills, and ability to influence, lead and drive change demonstrated through relevant work experiences.
Broad and integrated knowledge and experience that can impact project and workgroup direction.
Post Graduate Degree (Scientific, Engineering, Technical).
Knowledge of current and emerging Regulatory Strategies (Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9, Q10) and Product Lifecycle Management.
Demonstrated experience in the pharmaceutical industry in leading the technical aspects of Product Lifecycle Management.
Demonstrated knowledge of Quality by Design and risk management approaches
We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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. recruitment@gsk.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. 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.
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