Site Quality Director for Ware

Site Quality Director Ware Key responsibilities:

• Serves as a member of the site leadership team, working actively on Strategy deployment to support GSK Objectives.  Takes a leading role in developing and implementing Quality and Compliance strategies and initiatives.  Ensures full deployment of GSK’s Quality Management System (QMS), ensuring requirements are both in place and in use.  Develop, monitor, foster stepwise continuous improvement of key quality metrics.  Ensures appropriate Quality metrics are deployed effectively throughout the site and uses metrics to drive improvement
• Ensures GSK Values for Customer First, Respect for people, Transparency and Integrity are prioritized for decision making at the site.  Leads talent development / talent management activities for Quality staff
• Ensures staff development supports the needs of the Quality Unit
• Manages complex change programs across multi-faceted issues (e.g. people, products, etc.)
• Hosts regulatory agency inspections and assures site inspection readiness.  Ensures effective regulatory conformance and compliance programs are established
• Direct all Quality related functions for the manufacturing facility including validation and approval authority for the release of product to commercial while providing expertise in critical quality areas, such as chemistry, microbiology, manufacturing, packaging, and regulatory and validation.  Assists in identifying, developing and implementing new technologies and facility-wide process improvements
• Holds cross-functional responsibilities ranging from participation on product development teams through commercial launch for new products and lifecycle issues for on-going commercial products
• Ensures GSK records retention policy is in place and in use for site Quality records as well as complying with CIA requirements as a Manufacturing Covered Person
• Accountable for adequate Corrective and Preventive Action development arising from any critical or major audit findings and monitoring progress on a quarterly basis, at a minimum
• Ensures that Site Safety is championed as part of Leadership team, setting high standards for Safety, confronting risks, ensuring that all staff proactively engage in safety conversations and ensuring facility is maintained to the highest standard with safety work orders getting priority focus based on criticality

Requirements:

• Bachelor of Science degree (Biological Sciences, Chemistry, Pharmacy or related scientific discipline)
• Minimum 10 years of proven supervisory/management experience in Pharmaceutical Quality Assurance, Compliance, Quality Control or a related field, including a position of significant leadership and decision-making authority within Quality or a related function
• Experience devising and implementing regulatory compliance strategies and interacting with Regulators
• Experience with new product introduction, network change programs, technology transfer and supply chain management
• Must have good working knowledge of validation techniques and philosophy, as well as strong analytical, numerical and reasoning skills
• Excellent technical writing skills, verbal communication skills, and presentation skills
• Strong leadership skills, participative management style
• Experience in auditing internal and external sites/suppliers; negotiation and facilitation of corrective actions
• Extensive knowledge of cGMPs, FDA (or pertinent regulatory) guidelines, compliance requirements, facility registration, validation, labeling, regulatory submissions, annual reviews, regulatory reporting requirements and recalls

If Ware is not the right location for you, but you are interested in a Site Quality Director role with GSK, feel free to apply as well

*LI-GSK

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).

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