Quality Control Manager

Our Work Matters:

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

Role Overview:

In this role you will be responsible for the management of the Quality Laboratory function, ensuring all testing is carried out to pre-defined company procedures, methods, specifications and associated cGMP and customer requirements.  

You will support the operations business plan and ensure compliance to regulatory requirements with respect to Quality Laboratory function and set the strategic direction of the Laboratory with the site management team to drive productivity improvements.

Liaise with product stream managers, external customers, regulatory/project teams to provide expert advice on all matters relating to Quality Laboratory testing and processes.

Key Responsibilities include, but are not limited to:

• Maintain a safe working environment and work in compliance with agreed company procedures to maintain quality e.g. GMP, GLP, specifications, methods.
• Provide leadership, direction and support to Quality Improvement programs within Quality Laboratory using Six Sigma.
• Maintain documentation required for personal EPR process, including training records.
• Support and guide QC personnel with regards technical issues, company policy, site processes and GMP.
• Complete regular reviews for direct reports and input into MTR processes.
• Ensure QC personnel are appraised, with clear job accountabilities, whilst supporting development and training plans as appropriate.
• Appraise Customers, through technical interfaces and audits and company processes.  
• Discuss quality issues with customers, in compliance with Quality Agreements.
• Lead complex laboratory investigations to closure, working with key stakeholders and customers.
• Management of resource planning for the Quality Laboratory set through S&OP process and effectively manage daily quality & compliance issues.
• Preparation and input into management decision making processes for quality, steering teams and strategic site meetings.
• Review/approve SOPs, specifications, methods, protocols, reports, QIRs, CAPAs, planned deviations, stability reports, validation and other GMP documentation.
• Direct accountability for quality laboratory systems, project management and appraisal of new systems and their introduction.
• Champion and development of site compliance programs and training. 
• Responsible for the closure of audit actions in the Laboratory.
• Accountable for financial planning and delivery of agreed department budgets.

Skills & Experience:

• 5+ years’ experience working within a pharmaceutical laboratory.
• 5+ years supervisory/managerial experience.
• Degree qualified or equivalent in a life science degree.
• Knowledge of current pharmaceutical guidelines and regulations.
• Strong understanding of analytical techniques (HPLC, GC, UV, etc.).
• Knowledge of current GMP, MHRA, and FDA compliance expectations.
• Experienced in leading laboratory investigations and deviation/CAPA processes.
• Ability to remain audit-ready and manage external inspections effectively.
• Computer literate, familiar with Microsoft Word and Excel

Key Capabilities:

• Good organisational, interpersonal, and time management skills
• Enthusiastic, flexible, conscientious and proactive in approach
• Take a positive approach to own training and development
• Good decision making and problem-solving skills
• Strong verbal and numerical aptitude skills
• Good communication and leadership skills

What we offer:

• Attractive compensation package
• Company pension scheme (up to 10% employer contribution)
• 25 days holiday per year (plus bank holidays) plus service days after 5 years
• Company sick pay
• Employee Assistance Program with 24/7 confidential helpline support for employee and immediate family
• Life assurance of four times life cover salary
• Flexible working hours
• Wellness programmes
• Employee recognition program
• Employee development
• Free on-site parking
• Discount and cashback at many retailers
• Cycle to work scheme
• Flu vaccinations
• Employee referral scheme

Additional information: 

Working Hours: 37.5hrs per week

Location: Derby Road, Loughborough

All applicants must be eligible to work in the UK.

We believe our people make the difference at Kindeva Drug Delivery, we look for skilled, passionate, and driven professionals to come and work with us to help us excel in manufacturing technologies and processes, which bring lifesaving products to patients worldwide.

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