Global Sterility Assurance Director

Job title:

Global Sterility Assurance Director

Company

GlaxoSmithKline

Job description

The Global Sterility Assurance Director at GlaxoSmithKline (GSK) is a pivotal role within the Strategic Product Quality staff, bringing critical expertise in sterility assurance across various initiatives and projects within GSK’s internal and external commercial and R&D vaccine and medicine drug substance and drug product manufacturing sites. This role is essential in ensuring that both internal sterility assurance standards and external regulatory standards and guidance are comprehensively understood and effectively applied throughout the organization.A key responsibility of the Global Sterility Assurance Director is to partner with various teams, including those in Research & Development (R&D), Materials, Science & Technology (MSAT), Quality, and Operations, to ensure that Business Units (BU) as well as contract manufacturing organizations (CMOs) adhere to these stringent standards. The Director also identifies business solutions to enhance aseptic and low bioburden manufacturing processes, aiming to improve robustness and efficiency while building strong internal and external relationships with key stakeholders.Beyond these responsibilities, the Global Sterility Assurance Director plays a significant role in due diligence activities during onboarding processes, serves as the person in plant (PIP), and supports routine inspection and pre-approval inspection readiness through to filing and product launch. The Director is also involved in resolving ongoing incidents and deviations.The Global Sterility Assurance Director is a global staff member, acting as the primary point of contact for sterility assurance across all areas of the business, including departments such as Operations, Engineering, MSAT, and Quality Control (QC), as well as CMOs and third-party R&D/Technical Research and Development (TRD). The main duty of this role is to facilitate interaction between Quality and various sites or departments for the implementation of Quality Management System (QMS) standards and continuous improvement initiatives, including KPI trending and capability development in sterility assurance domains and process confirmations. This position is crucial for embedding GSK’s sterility assurance strategy into specific operations and ensuring that future processes and products are developed with sterility by design. Given the high pressure from regulatory agencies on sterility assurance issues, the role is strategic for ensuring the proactive installation of appropriate sterility assurance standards (QMS and standard work) across the business and operations. Additionally, the Director plays a central role in remediation plans following any regulatory observations, making it a highly strategic and impactful position within the organization.Key Responsibilities

• Facilitate interactions between Global sterility assurance and the business units under its responsibility by establishing working relationship (Service Level agreement using Key Performance Indicators) with the leaders and main contact people.
• Act as a main point of contact for the Business units in supporting the implementation of GSK Sterility Assurance Strategy
• Is the point of contact for supporting the business units in the establishment of the annual Contamination Control Strategy or Sterility Assurance Road map
• Support Business units in the execution of the annual CCS in the different sterility assurance domains and processes (training, trouble shooting, coaching/mentoring, specific projects) and perform process confirmations on targeted topics
• Partnership with business units for Key Performance Indicators analysis, trending and escalation, gap assessment versus standards including (Sterility Assurance GQP’s and QMS, FDA Guidance, etc.)
• Review with business units the annual performance in Sterility Assurance and help on the preparation of the next CCS
• Assure availability of Sterility Assurance experts for supporting Business units in a specific domain according to annual CCS priorities.
• Accountable for alignment in way of working and standard works between Business units in Sterility Assurance subjects.
• Is the Sterility Assurance quality generalist and therefore act as SPOC 9Single Point of Contact) in case of issue/question raised by the Business units.
• External advocacy: Lead or influence proactively Sterility assurance external trade associations.
• Developing Capability: Supporting the development of sterility assurance capability across key areas of the business through delivery of training, coaching and mentoring.

Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:

• Bachelor degree in a Scientific Discipline
• Significant experience in aseptic or bioburden control manufacturing environment (production, QA, validation) with demonstrated successful results, preferably in FDA regulated environment
• In depth knowledge of regulations, guidance, best practices and industry standards related to sterility assurance (for example: GSK, GMP, WHO, PDA, ASTM, ISPE, PhRMA, etc.) including review of regulatory files
• Strong technical and quality skills in sterility assurance issue
• Coaching and mentoring capabilities for shopfloor training and education

Preferred Qualifications:If you have the following characteristics, it would be a plus:

• Excellent ability to influence, challenge and educate the leadership teams in sterility assurance to optimize Vaccines operations
• Personal credibility, confidence and robustness to drive and influence senior colleagues
• Ability to make persuasive recommendations based on rationale analysis
• Ability to network internally and externally and to communicate to a wide base of partners
• Strong verbal and written English language skills
• Strong capability to work in matrix organization inside Sterility Assurance team and outside in GSK networks
• Resilience, capacity for adapting in different environment and resistance to pressure

APPLICATION CLOSING DATE – 8 December 2024Please 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.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 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/ AgenciesGSK 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 site.

Expected salary

Location

Barnard Castle, County Durham

Job date

Sun, 24 Nov 2024 04:34:23 GMT

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