QC Manager

• Oversee the execution of compliance activities according to established schedules and procedures, ensuring documentation such as SOPs, Certificates of Inspection (COIs), and other quality documents are current and accessible.
• Manage deviation investigations and ensure effective implementation and closure of CAPAs.
• Support internal and external audit activities.
• Monitor laboratory trends and take proactive measures where necessary.

• Plan and oversee testing schedules for raw materials, in-process samples, finished goods, pilot batches, and validation studies to support timely product release.
• Ensure data verification meets integrity and accuracy standards.
• Manage the stability testing program, including investigation of out-of-specification results and communication with regulatory bodies and clients when needed.
• Support new product introduction by coordinating required analytical testing as outlined in project plans.
• Lead, support, and develop the QC team to meet output goals and deadlines.
• Ensure all laboratory work complies with applicable regulatory standards.
• Provide technical support in resolving testing-related issues such as equipment malfunctions, calibration errors, and method deviations.
• Drive root cause analysis for analytical issues or deviations.
• Monitor and manage laboratory expenditures within the approved annual budget.

• Ensure a safe working environment within the laboratory and compliance with all health and safety protocols.
• Coordinate safety initiatives, including risk assessments and training, in collaboration with the EHS team.

• Ensure all QC personnel are appropriately trained and competent.
• Coordinate internal and external training programs to support staff development and technical skill advancement.

• Proven leadership and people management experience with the ability to inspire and motivate a team.
• Strong organisational and time management skills with a capability to handle multiple priorities effectively.
• Proficient in IT systems and analytical instrumentation; familiar with key quality control software and techniques.
• Strong commitment to ALCOA+ data integrity principles.
• Excellent interpersonal and communication skills.
• High-level analytical thinking and problem-solving abilities.
• Structured, methodical approach to managing projects and laboratory operations.
• Results-driven and proactive mindset with a practical approach to leadership.

• Bachelor's degree in a science-related discipline.
• Minimum of 5' experience in the pharmaceutical industry, with at least 2 years in a senior QC or management role.
• In-depth knowledge and hands-on experience within a GMP-regulated QC laboratory environment.
• Understanding of both EU and US GMP guidelines.

Morgan McKinley