Are you looking for an opportunity to be a leader in Site Quality control systems for a multi-national pharmaceutical company? If so, this is the role for you.
As Site Quality Lead , you will serve 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
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Key responsibilities
- 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.
- Strategy deployment:
- Actively involve and engage on Strategy deployment to support GSK Objectives.
- Operational Procedure:
- Manages complex change programs across multi-faceted issues (e.g. people, products, etc.)
- 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
- Oversee resources - manpower, CAPEX and revenue budgets to be in line with set objectives at site.
- Escalate quality risks and raise them in RMCB/Regional Quality Council.
- 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
- Regulatory review Quality performance and ensure compliance.
- Drive and interface Quality improvement activities and monitor their effectiveness in the Quality Team as well as Site Leadership Team.
- To sponsor and contribute to Continuous improvement initiatives through use of GPS.
- Ensure compliance of all local regulatory compliance procedures with the Ministry of Health as well as other stakeholders.
- Work with procurement in their initiatives for source changes
- 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.
- Audit/Risk Management:
- Hosts regulatory agency inspections and assures site inspection readiness. Ensures effective regulatory conformance and compliance programs are established
- Facilitate Level 1 & 2 Audits and oversee their implementation across the board
- Supervise and ensure action plans in response to post audit results.
- Facilitate Global Quality Audits as well as all Quality System audits across site.
- Play an active role in risk mitigation planning and give active advice for improvements.
- Ensure that Quality Lab functions are compliant with local regulatory requirement & QMS.
- Ensure audits of third-party suppliers through Supplier Quality
- Product Development:
- Oversee new development initiatives.
- Facilitate in the implementation of new products & steaming process tom suite business needs.
- Support Pharma operations for all new initiatives
- People Management and Development:
- Ensures staff development supports the needs of the Quality Unit
- Ensure adequate trainings are conducted with regard to understanding various technicalities, specifications of different systems, regulation and requirements.
- Formulate rotation, career, succession, and training plans for the Quality team and discuss with the Human Resource Manager to ensure their comprehensive development plans are in line with the business objectives.
- Ensure best-fit recruitment of individuals according to the Position Profile / Job specification.
- Carry out performance appraisals of the reporting team members, as per the individual goals set for the year.
- Implement departmental and individual objectives of the Quality Department and take appropriate measures to streamline any deviations or hindrance in achieving the goals.
- Be a Role Model on Leadership Essential Behaviours.
- Job Dimensions - Breadth/ Scope of Accountability
- Maintenance of Drug Manufacturing Licenses to assure product can be manufactured, tested and released in accordance with all relevant regulations and QMS requirements
- Ensure compliance of all local Regulatory compliance procedures with the Ministry of Health as well as other stakeholders.
- Ensure compliance to cGMP and QMS and its implementation at site.
- Embedding a compliance culture at the site ensuring successful audit and inspection outcomes
- Release of product of high quality that is safe and effective with no disruption to the supply chain.
- Ensure adequate Quality oversight on site operations.
- Sponsor and contribute to improvement initiatives through use of GPS. Oversee new development initiatives. Facilitate in the implementation of new products and streamlining process to suit business needs
- Ensure EHS Compliance as per the required standards
- Provide necessary leadership to enable all aspects of EHS in order to ensure that department operates in such a way as to provide a healthy and safe working environment for the staff
- Ensure that the laboratory is compliant with local regulatory requirements and QMS.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor of Science degree (Biological Sciences, Chemistry, Pharmacy or related scientific discipline)
- Minimum 8-10 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, pertinent regulatory) guidelines, compliance requirements, facility registration, validation, labeling, regulatory submissions, annual reviews, regulatory reporting requirements and recalls
Post Closure Date: 9.Oct.2024
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.
Contact information:
You may apply for this position online by selecting the Apply now button.
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