Head of Qc

**Head of QC - Pharmaceuticals**

**Livingston**

Our client, an international pharmaceutical organisation is looking to recruit an experienced Head of QC to join the senior management team providing leadership and direction to multiple QC teams across a highly regulated GMP facility.

**Your remit will include -**
- Direct and oversee the quality control department and senior QC staff
- Recruit, lead, manage and develop the Quality Control department staff and manage the organisational structures, policies, procedures and processes necessary to ensure effective, efficient and accountable use of these resources
- Assuring compliance of all QC facilities, systems, processes and best work principles according to the regulations and necessary to ensure visibility of all analytical test data (i.e. from samples taken from starting materials / components and product)
- Be responsible for the development, collating and reporting of key quality and business metrics and use such metrics to drive a Quality culture of continuous process improvement
- On a day to day basis plan, co-ordinate and manage QC test plans in order to deliver product to appropriate time, quality and costs including the technical oversight of all external QC testing activities
- Overall responsibility for ensuring that all required QC sampling and analysis / testing and associated reports for QC and Microbiology are completed and trending is being performed according to the requirements of regulatory documentation (e.g. BLA, CMA)
- Responsible for the review of QC test data (i.e. compilation of batch documentation and assessment of compliance with specifications) and for final QC decisions / authorisation in support of the release / rejection of materials and products
- Responsible for the investigation and reporting of all emerging trends, Out of Specification (OOS) and Out of Trend (OOT) analytical QC results
- To immediately escalate any material breach of quality or regulatory compliance matters to the Director of Quality Operations and to ensure that the QP and other key staff are kept fully informed with respect to all QC test results which may have an impact on batch / lot release decisions
- To keep up to date with current guidelines, pharmacopoeia monographs and scientific knowledge in respect of QC testing requirements and methods
- Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the QC team setting
- Conduct performance evaluations for direct reports. Manage discipline and termination of employees in accordance with company policy
- To provide technical support to key operational matters and coordinate where appropriate technical expertise from within QC to support key investigations and technical matters

**Experience / Skills**
- Relevant QC management experience in a regulated industry ideally within a biopharma/ pharma environment
- Experience of EU, FDA and cGMP requirements of the manufacture and testing of biopharmaceutical / medical device products in a commercial environment
- Thorough understanding of quality control standards and methodologies
- Educate to degree level, or equivalent experience
- Experience of directly managing QC teams
- Self-starter manager with proven track record in the effective management of QC laboratories
- Ability to motivate and engage a productive workforce
- Good understanding and knowledge of the Pharmaceutical Industry
- Strong analytical and problem-solving skills
- Strategic thinker with the ability to influence at senior level
- Implementation and management of procedures tracking systems.

**Rewards**

This is an excellent opportunity to join a leading scientific organisation in a highly varied role. In return, the company will offer a highly competitive basic salary, plus attractive bonus, private medical/dental care, gym membership, attractive pension & more


**Job Types**: Full-time, Permanent

**Benefits**:

- On-site parking

Schedule:

- 8 hour shift
- Monday to Friday

Supplemental pay types:

- Bonus scheme

**Experience**:

- QC management: 10 years (preferred)
- supervisory: 10 years (preferred)

Licence/Certification:

- Driving Licence (preferred)

Work Location: One location