Vice President Sterility Assurance jobs in United States
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GSK · 6 hours ago

Vice President Sterility Assurance

GSK is a global biopharma company focused on uniting science, technology, and talent to advance healthcare. The Vice President of Sterility Assurance will lead the development and implementation of global sterility strategies, ensuring compliance and quality across the manufacturing network.

BiotechnologyHealth CarePharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Own and deploy sterility assurance strategy, standards, and governance to ensure compliance to regulatory expectations
Lead cross-functional alignment and risk mitigation across Engineering, QA, and MSAT
Ensure contamination control strategy is standardized and embedded in QMS
Oversight of facility design and equipment reliability aligned with sterility assurance requirements
Lead cleaning validation, process control, and supplier qualification as it relates to sterility assurance standards
Ensure QMS integration, deviation management, and inspection readiness
Chair monthly governance forums and drive strategic decisions
Build capability through Communities of Practice
Accountable for transformation of sterility assurance global standards across Engineering, MSAT and Quality and ensuring that they are in use across all sites
Set vision for the future to proactively meet regulatory expectations
Accountable for program management for execution / implementation to global standards
Deliver Annex 1 compliance through standardized global policies
Implement KPI dashboards for contamination control and cleaning validation
Define clear project and governance frameworks to clarify roles and responsibilities between global and local teams
Drive continuous improvement and proactive inspection readiness
Lead the uplift in capability building and leadership development across functions
External network/advocacy with industry forums and regulators to keep pace with evolving regulatory expectations and emerging technology

Qualification

Sterility assuranceMicrobiologyQuality Assurance (QA)Regulatory complianceAnnex 1 knowledgeGMP knowledgeInspection readinessStakeholder managementLeadershipCommunication skills

Required

Bachelor's degree in microbiology, life sciences, engineering, or related field, or equivalent experience
Significant experience in sterility assurance, microbiology, or quality in a regulated manufacturing environment
Proven leadership in cross-functional roles including QA, Engineering, and MSAT
Strong knowledge of Annex 1, GMP, and global regulatory requirements
Experience in inspection readiness
Excellent communication, governance, and stakeholder management skills

Preferred

Advanced degree in microbiology, pharmaceutical sciences, or engineering

Benefits

Annual bonus
Eligibility to participate in our share based long term incentive program
Health care and other insurance benefits (for employee and family)
Retirement benefits
Paid holidays
Vacation
Paid caregiver/parental and medical leave

Company

We are uniting science, technology and talent to get ahead of disease together. Our community guidelines: https://gsk.to/socialmedia

H1B Sponsorship

GSK has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (56)
2023 (54)
2022 (53)
2021 (54)
2020 (72)

Funding

Current Stage
Public Company
Total Funding
$25.51M
Key Investors
CARB-X
2021-03-02Grant· $18M
2020-09-23Grant· $7.51M
1978-01-13IPO

Leadership Team

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Julie Brown
CFO
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Mike Elmore
SVP & Chief Information Security Officer, GSK
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Company data provided by crunchbase