Regulatory Conformance Specialist in Ware

The Quality function promotes quality and compliance through the product life-cycle in the manufacturing and production operations across GSK Sites. The team supervises all Regulatory compliance related systems, improvement procedures and documentation (including analytical data and information) to ensure products released have been manufactured and packaged according to all Regulatory and cGMP requirements (including appropriate certification for the UK/EU markets).

As (Regulatory) Conformance Specialist you will develop and provide input to regulatory strategies, change control and compliance issues for the manufacture and registration of established API (Active Pharmaceutical Ingredients), Finished Products and New Product Introductions (NPIs). The role ensures site compliance by the interpretation of corporate standards (e.g. the QMS), pharmacopoeial requirements, regulatory authority directives, license renewals/annual reports and commitments made to regulatory authorities. You will support the Quality Assurance department and all manufacturing units across the site by handling compliance to all licences in all markets supplied (directly or via a packaging site).

Key Responsibilities:

• Act as product regulatory specialist for the site.
• Provide product regulatory advice for the impact of all changes made on site ensuring regulatory compliance in all markets.
• Maintain product quality specifications to ensure manufacturing and release and end of life testing complies with registered details and pharmacopoeial requirements.
• Provide and approve regulatory information for periodic product reviews.
• Lead NPI submissions and reviews working with site SMEs and central/local functions to meet GSK submission & launch dates.
• Ensure robust evaluation of registered detail that will be submitted to allow future operational flexibility and ensure compliance.
• Act as the primary site contact with central regulatory groups (pre and post approval) and Local Operating Companies (LOCs).
• Develop regulatory strategies using innovative thinking to support site and business strategies/priorities.
• Review and approve all regulatory documents (submissions, variation dossiers, licence renewals, response to questions and annual reports).
• Support regulatory compliance on site: Internal and external audits, Regulatory/Pharmacopoeial Intelligence, and maintain statutory Site licenses.
• Lead or assist with quality and compliance-related deviations.

About You:

As this role is multi-faceted and includes liaising with a wide variety of on-site production and operations teams, you will be a self-motivated person who has experience of working in regulatory, quality and/or manufacturing at a complex manufacturing site. You will be resilient and calm under pressure, with strong people skills. You will have a strong continuous improvement mindset. Effective written and verbal communication and excellent interpersonal skills, as well as the ability to organise and prioritise workload are considered essential skills.

Basic Qualifications:

• Relevant qualifications (e.g. HND or ‘A’ levels in scientific, technical engineering discipline) and/or equivalent experience (ideally gained working in a Pharmaceutical Manufacturing Facility or similar highly regulated industry).
• Experience of managing regulatory compliance or regulatory affair-processes related activities within a pharma or consumer supply chain environment.
• Knowledge of current Good Manufacturing Practice (cGMP) requirements.
• Experience obtained working in highly regulated industry, including knowledge and application of the principle of the Quality Management Systems (QMS).

Preferred Qualifications:

• Experience in regulatory affairs, particularly post-approval licence maintenance and variation submissions, would be preferred but is not compulsory.

Benefits:

GSK offers a range of benefits to its employees, which include, but are not limited to:

• Competitive base Salary
• Annual bonus based on company performance
• Opportunities to partake in on the job training courses
• Opportunities to attend and partake in industry conferences
• Opportunities for support for professional development/chartership
• Access to healthcare and wellbeing programmes
• Employee recognition programmes

If you would like to learn more about our company wide benefits and life at GSK we would suggest looking at our webpage Life at GSK | GSK.

Why GSK?

Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive.

We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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.