Qc jobs in United States

Bishop Meadow Rd, Loughborough LE12, UK Req #1805

Tuesday, May 6, 2025

Our Work Matters:

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

Role Overview:

This role involves managing the Quality Laboratory function, ensuring all testing complies with company procedures, methods, specifications, cGMP, and customer requirements. You will support the operations business plan, ensure regulatory compliance, and set the strategic direction of the Laboratory with the site management team to drive productivity improvements. You will liaise with product stream managers, external customers, and regulatory/project teams to provide expert advice on Quality Laboratory testing and processes.

Key Responsibilities include, but are not limited to:

• Maintain a safe working environment and ensure compliance with GMP, GLP, specifications, and methods.
• Provide leadership and support for Quality Improvement programs within the Laboratory using Six Sigma.
• Maintain necessary documentation for personal EPR processes, including training records.
• Support and guide QC personnel on technical issues, company policies, site processes, and GMP.
• Conduct regular reviews for direct reports and contribute to MTR processes.
• Ensure QC personnel are appraised, with clear job responsibilities, and support their development and training.
• Engage with customers through technical interfaces and audits, discussing quality issues in accordance with Quality Agreements.
• Lead complex laboratory investigations to resolution, collaborating with stakeholders and customers.
• Manage resource planning for the Quality Laboratory through the S&OP process and handle daily quality and compliance issues.
• Participate in management decision-making processes related to quality, steering teams, and site strategy meetings.
• Review and approve SOPs, specifications, methods, protocols, reports, QIRs, CAPAs, deviations, validation documents, and other GMP-related documentation.
• Take accountability for laboratory systems, project management, and the introduction of new systems.
• Champion and develop site compliance programs and training initiatives.
• Ensure timely closure of audit actions within the Laboratory.
• Manage the department's financial planning and budget delivery.

Skills & Experience:

• Minimum 5 years’ experience in a pharmaceutical laboratory.
• At least 5 years of supervisory or managerial experience.
• Degree qualified or equivalent in a life science discipline.
• Knowledge of current pharmaceutical guidelines and regulations.
• Strong understanding of analytical techniques (HPLC, GC, UV, etc.).
• Familiarity with GMP, MHRA, and FDA compliance standards.
• Experience leading laboratory investigations and deviation/CAPA processes.
• Ability to manage external inspections and remain audit-ready.
• Proficiency in Microsoft Word and Excel.

Key Capabilities:

• Strong organizational, interpersonal, and time management skills.
• Enthusiastic, flexible, and proactive approach.
• Commitment to personal training and development.
• Excellent decision-making and problem-solving skills.
• Strong verbal and numerical communication skills.
• Effective leadership and communication abilities.

What we offer:

• Attractive compensation package.
• Company pension scheme (up to 10% employer contribution).
• 25 days holiday per year plus bank holidays and service days after 5 years.
• Company sick pay.
• Employee Assistance Program with 24/7 confidential support.
• Life assurance of four times salary.
• Wellness programs.
• Employee recognition initiatives.
• Free on-site parking.
• Retail discounts and cashback offers.
• Cycle to work scheme.

Additional information:

Location: Derby Road, Loughborough

All applicants must be eligible to work in the UK.

At Kindeva Drug Delivery, we value our people and seek skilled, passionate, and driven professionals to help us excel in manufacturing technologies and processes that deliver lifesaving products worldwide.