Role: Quality Director - Pharma
Location: North West, UK
Russell Taylor Group has an excellent opportunity for a Quality Professional to lead and manage the strategic and operational performance of the Quality function, ensuring the successful delivery of business strategy, Key Performance Indicators (KPIs) and objectives, whilst adhering to regulatory compliance and achieving commercial success. To ensure the efficient and effective day to day running of the Quality department, through the management of the Quality Assurance, Quality Control, Laboratory and Validation teams.
- Developing and implementing the Quality Department's strategy, to ensure it meets the business requirements and customer deliverables, as well as ensuring the departmental performance against goals.
- Implementing and monitoring all Quality Assurance systems to ensure compliance with EU Commission Directive 2003/94/EC, covering GMP for medicinal products for human use and investigational medicinal products (IMPs) for human use.
- Implementing and maintaining a Quality Risk Management system to ensure that risks are adequately controlled in accordance with current requirements (EU GMP Part III Q9).
- Acting as the main point of contact on all Quality matters, internally and externally.
- Coordinating and leading all customer and regulatory inspections/audits
- Maintaining MHRA compliance, including submission of variations (named on licences as responsible for overall Quality Compliance).
- Maintaining and improving departmental operational performance, to meet the requirements of regulatory authorities, company Standard Operating Procedures (SOPs) and external and internal customers, with respect to quality, service, lead time and cost.
- Ensuring the development of departmental SOPs, ensuring regulatory compliance in conjunction with being 'fit for purpose' operationally and commercially.
- Ensuring that all activities are performed in accordance with GMP, company SOPs and Environment, Health and Safety policies.
- Ensuring that the supplier and subcontractor audits are performed and reported as scheduled.
- Ensuring that there is a self-inspection programme in place which is communicated to all departments to meet the requirements of EU GMP.
- Managing all validation activities, including validation strategy.
- Maintaining an awareness of new and proposed legislation that impacts the business and communicating any changes to the Senior Management Team and the wider business.
- Ensuring the availability of suitably trained and competent resources to carry out the review and approval batch documentation in accordance with in-house and GMP requirements.
- Ensuring that sufficient QP resources are available at all times to provide QP certification for all products.
- Act as releasing QP for the site in accordance with EU Directive 2001/83/EC and Eurdralex Volume 4 Annex 16 when required.
- Reviewing and approving Technical and Quality Agreements.
- Ensuring appropriate and timely investigation is undertaken of discrepancies, errors, complaints, failures or adverse events, both internally and externally.
- Ensuring that the Quality departments meet or improve on budget, cost, volume and efficiency targets (KPIs) in line with business objectives.
- High level resource planning.
- Providing direction and guidance to direct reports and to the wider Quality team.
- Managing, motivating, coaching and mentoring direct reports, to higher levels of management capability.
- Identifying and developing the Quality team structure.
- Preparing and justifying the Quality department's budget.
- Eligible to act as a Qualified Person in accordance with directive EC/2001/83.
- Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
- Good understanding of the pharmaceutical markets.
- Wide knowledge of processes used in the manufacture and packaging of oral solid dose medicinal products.
- Strong leadership/team management skills and experience.
- Credible and confident communicator (written and verbal) at all levels.
- Strategic thinker with the ability to influence at a senior level.
- Strong analytical and problem-solving ability.
- Excellent project management skills.
- First class presentation skills (written and verbal).
- Hands-on approach, with a 'can do' attitude.
- First class organisational skills.
- Ability to prioritise, demonstrating good time management skills.
- Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
- Self-motivated, with the ability to work proactively using own initiative.