QA Manager

Job Specification: Senior Manager, Quality Control Laboratory

Overview: A leading global manufacturer is seeking a Senior Manager, QC Lab to drive quality, compliance, and continuous improvement initiatives. This role ensures regulatory adherence, optimizes laboratory operations, and advances global and local quality strategies.

Location: Petersfield, Hampshire, UK

Key Responsibilities:

1. Management of QC Lab Testing
2. Lead daily QC lab operations to ensure raw materials, mass, and finished goods meet specifications.
3. Manage lab workflow, sample analysis, retention, standards, raw material qualification, TPM testing, outsourced testing, inventory, and documentation.
4. Review execution and KPIs related to data integrity checks.
5. Provide QC expertise for plant hygiene, environmental monitoring, and risk assessments.
6. Liaise with suppliers, R&D, SAS, and other departments regarding test procedures and specification discrepancies.
7. Update SOPs and work instructions based on lab trends and CAPAs.

Testing Data Review & Release:

1. Review and approve routine test data, including sample preparation records, chromatograms, logbooks, calculations, and data sheets.
2. Enter test results into SAP/LIMS and oversee the release of raw materials, non-OTC mass, and cosmetic finished goods.
3. Review non-routine test data, including microbiological testing for water systems and validation testing.

Equipment Program Management:

1. Lead QC lab equipment budget, purchases, installations, and change control.
2. Review and approve lab equipment qualification protocols and reports.
3. Oversee QC lab equipment administration, including calibration, preventive maintenance, and troubleshooting.

Compliance & Continuous Improvement:

1. Ensure lab processes adhere to regulatory GMPs, company policies, and procedures.
2. Participate in internal audits to maintain regulatory readiness.
3. Collaborate with Planning, GBSC, QA Labs, Manufacturing, Validation, and Operations to drive continuous improvement.
4. Monitor and analyze lab KPIs, implementing improvement strategies.
5. Investigate customer complaints, implement corrective actions, and ensure timely resolutions.
6. Support plant and global compliance programs, focusing on GMP, Data Integrity, and GDPR.

Personnel Management & Training:

1. Align QC Lab Managers' objectives with company and QA strategy goals.
2. Partner with Quality leadership for succession planning and fostering a high-performance culture.
3. Provide coaching, mentorship, and training for QC lab staff.
4. Develop and implement a quality training curriculum for laboratory personnel.

Candidate Profile:

Qualifications:

Minimum of eight years' experience in managerial roles, preferably within microbiology, analytical chemistry, or product evaluation laboratories in Quality Control for a global consumer goods or pharmaceutical company.

Experience and Knowledge:

1. Proven ability to manage multiple laboratories in a cGMP environment.
2. Experience in developing and overseeing laboratory SOPs and revisions according to regulatory guidelines.
3. Experience handling microbiological and analytical chemistry data integrity requirements necessary in an HC/FDA/global government agency inquiry and/or audit.
4. Proficiency in statistical data assessment for quality control and decision-making.
5. Proficiency in Microsoft Office Suite, Electronic QMS, and SAP systems is preferred.

Skills and Competencies:

1. Communication & Coaching: Ability to clearly and concisely convey quality control requirements, issues, and program implementation to team members. Skilled in guiding cross-functional stakeholders and suppliers through quality control processes and corrective actions.
2. Leadership & Collaboration: Strong leadership and interpersonal skills to effectively manage teams, foster collaboration, and drive quality initiatives.
3. Problem-Solving: Exceptional analytical skills to identify issues, develop solutions, and implement corrective and preventative actions.
4. Data Analysis & Statistical Assessment: Expertise in evaluating data trends and applying statistical methods to enhance quality control and decision-making.

Additional Information: This is an exciting opportunity for individuals looking to make an impact within a global manufacturing environment. If you are passionate about quality control and innovation, we encourage you to apply.