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Director, Quality and Risk Management
4 months ago
Site Quality Director
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. 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. 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.
The Quality team supports the delivery of effective, efficient, and compliant performance at the GSK, Montrose manufacturing site .The Site Quality Director is accountable for the delivery of all aspects of the Quality function at the site including Operational Quality, Quality Control, Validation, Compliance, Regulatory, Analytical Development and capital project support. The SQD must lead and support the wider team to ensure excellent GMP standards, continuous improvement of processes and systems, embedding excellence in quality culture, developing the quality team, and engaging the broader site organization.
The Site Quality Director will be based at the UK- Montrose Manufacturing facility.
Accountable for developing and delivering the Quality Strategy for the Montrose site. Collaborating with SLT functional leads to create an achievable and aligned quality plan.
Accountable for the compliant testing and release of all raw materials, intermediates, and finished drug substance (including stability testing) to support the delivery of high-quality API to the customers on time. Maintaining the supply chain needs ensuring our customer gets the medicines at the right quality when they need them.
Accountable for the quality oversight of the manufacture of intermediates and API’s, ensuring they are manufactured in compliance with our licenses and regulatory requirements. Including oversight of cleaning validation and verification, and plant turnarounds.
Set and maintain site GMP standards for the site and ensure inspection readiness at all times ensuring QMS in use with both informal process confirmation and formal audit processes to confirm and continually evolve and improve the standard.
Host internal corporate audits and external inspections, the site is subject to inspection from FDA, MHRA, MAH and external customers. Accountable for the audit readiness and management of inspections.
Provide leadership and coaching to all functions of the site quality team to ensure the team feels; Maintain and encourage continuous improvement mindset for all within the department, and other directorates on the topic of quality CI.
Responsible for capability build, including developing the digital competencies in quality and collaborating with central teams, working closely together to realize GSC Quality ambition.
Develop and lead on strategic and compliance requirements within the quality directorate and the site.
Deputise for the VP, Primary & Small Molecule Quality when required.
Bachelor's degree in science, preferably chemistry or related fields.
Extensive experience in pharmaceutical quality assurance management from an operational quality related role.
Demonstrated industry knowledge and experience with quality management challenges.
Expertise with quality standards in both primary and or secondary manufacturing.
MSc, PhD in a science-based subject.
Ability to adapt, work under uncertainty and accommodate flexible work demands with sensitivity.
Demonstrated track record of quality decision making and creative problem resolution in critical situations, demonstrates balanced judgement.
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. 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 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).
As an Equal Opportunity Employer, we are open to all talent. 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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