AddressPosted Date: Jun 28 2024
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. 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.
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.
Key Responsibilities include, but are not limited to:
- 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; engaged, developed, capable and valued. Responsible for having robust succession plans in place.
- 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.
- Ensure sufficient resource is in place to deliver a balanced level of support to the site.
- Deputise for the VP, Primary & Small Molecule Quality when required.
Why you? Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in science, preferably chemistry or related fields.
- Considerable leadership and Influencing skills across multiple levels of the organisation.
- 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.
Preferred Skills
If you have the following characteristics, it would be a plus:
- Higher degree e.g., MSc, PhD in a science-based subject.
- Ability to adapt, work under uncertainty and accommodate flexible work demands with sensitivity.
- Ability to adjust behaviours and priorities based on changing environment and manage stakeholders.
- Demonstrated track record of quality decision making and creative problem resolution in critical situations, demonstrates balanced judgement.
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 CV will be used to assess your application.
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 Ukdiversity.recruitment@gsk.com or 0808 234 4391.
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