QC Manager

4 weeks ago

Galway, Ireland Morgan McKinley Full time

Role Overview:

The QC Laboratory Manager will be accountable for the overall operation of the Quality Control Laboratory, including compliance oversight, stability testing, raw material and finished product testing, and product release.

Key Responsibilities:

- 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.

Skills & Competencies:

- 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.

Qualifications & Experience:

- 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.

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