QA Team Leader (Compliance)

Piramal-Pharma-Solutions; Grangemouth; On-site; GBP 65,000 - 95,000; Full time

Job summary

Piramal Pharma Solutions in Grangemouth is seeking a QA Team Leader (Compliance) to own elements of the Pharmaceutical Quality Management System across the site. You will provide quality and compliance expertise, identify risks, resolve issues and drive continuous improvement in collaboration with Quality, Manufacturing, Engineering, Supply Chain and IT.

The role requires strong GMP experience, GxP knowledge and the ability to influence stakeholders at all levels.

Qualifications

• Experience within Quality Assurance in a GMP environment.
• Strong knowledge of GxP requirements and relevant UK, EU, US and ICH quality guidance.
• Experience performing self-inspections and/or audits of third-party suppliers.
• Experience monitoring Quality Management Systems, including deviations, investigations, CAPA and complaints.
• Experience implementing audit and vendor assurance processes.
• Strong attention to detail, risk-based decision-making and communication skills.
• Lead Auditor qualifications or MHRA/FDA inspection support experience is advantageous.

Responsibilities

• Provide governance across key elements of the Pharmaceutical Quality Management System.
• Coordinate Quality Management Reviews and translate trends into actions.
• Support supplier qualification and audit programmes, including self-inspections and vendor audits.
• Assist regulatory inspections and post-inspection follow-up.
• Identify GxP trends and develop mitigation plans with stakeholders.
• Coordinate site QMS training and maintain understanding of regulatory requirements.

Skills

Quality Assurance

GxP compliance

Auditing

Regulatory liaison

Risk assessment

Education

Bachelor's degree in a relevant field

Tools

QMS software

Job description

Be the First to ApplyDivisionPiramal Pharma SolutionsPiramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.For more details, please visit : www.piramalpharmasolutions.comJob TitleQA Team Leader (Compliance)Job DescriptionReady to take the next step in your Quality career and have a real impact on how pharmaceutical quality is delivered?We’re looking for an experienced QA Team Leader (Compliance) to join our Quality team at Piramal Pharma Solutions in Grangemouth.This is an opportunity to take ownership of important elements of our Pharmaceutical Quality Management System, working across the site to strengthen compliance, identify improvement opportunities and support a robust, inspection-ready quality environment.The OpportunityThis is much more than maintaining quality systems.You’ll work closely with colleagues across Quality, Manufacturing, Engineering, Supply Chain, IT and Development, providing quality and compliance expertise while helping teams identify risk, resolve issues and continuously improve the way we work.You’ll have the opportunity to:Provide governance and oversight across key elements of the Pharmaceutical Quality Management System.Coordinate Quality Management Reviews and help turn quality and compliance trends into meaningful actions.Support supplier qualification and audit programmes, including self-inspections, vendor audits and customer audits.Support regulatory inspections and ensure effective pre-audit preparation and post-audit follow-up.Identify GxP trends and compliance risks and work with stakeholders to develop effective mitigation plans.Support quality investigations and the development and approval of effective CAPAs.Coordinate site QMS training and help maintain understanding of current regulatory and quality requirements.Work across the site to identify and implement continuous quality improvements.Maintain awareness of evolving quality standards, guidelines and industry best practice.About youWe’re looking for someone who can bring strong technical quality knowledge and confidently work with stakeholders across the business.You’ll ideally have:A degree in a relevant scientific, business, process or industrial engineering discipline.Experience within Quality Assurance in a GMP environment.Strong knowledge of GxP requirements and relevant UK, EU, US and ICH quality guidance.Experience performing self-inspections and/or audits of third-party suppliers.Experience monitoring Quality Management Systems, including deviations, investigations, CAPA and complaints.Experience implementing audit and vendor assurance processes.Strong attention to detail, risk-based decision-making and communication skills.The confidence to influence peers, senior managers and external stakeholders.Even better if you have Lead Auditor qualifications, experience supporting MHRA/FDA inspections, or experience maintaining pharmaceutical regulatory authorisations or Drug Master Files.Why this role?For an experienced QA professional, this role offers a particularly broad compliance remit. Rather than focusing on a single quality process, you’ll be involved across QMS governance, audits, regulatory compliance, CAPA, training, supplier assurance and continuous improvement, with significant interaction across the Grangemouth site.