Head of Quality

Pharmaceutical
c£80-120,000 plus package

This is an outstanding opportunity to take the key role in one of the North-West’s most exciting SME Pharmaceutical businesses

Recent M&A activity has seen their growth accelerate and their market penetration grow; North-West based but with an international customer base. Their still ongoing M&A strategy, complimenting group wide investment and organic growth, has seen them rise to one of the most influential businesses in their sector.

They are a well established, profitable but still very entrepreneurial and possess a very strong balance sheet and have a clear long-term growth & development strategy. 

Technical strength and capability has long been the strength of all the Group’s divisions with approximately a third of their overall employees being in scientific and/or technical functions across multiple business units.  They have furthermore developed a list of highly enviable and high-profile clients and possess a reputation for class-leading service-delivery, but their potential is so much greater.

The business is performing well but is focused on further cementing their market position, and increasing their market share whilst re-investing in the businesses to further accelerate their growth and financial position. This appointment is a key element of that.

This is a fantastic time to join this impressive group, as they hit a pivotal time in their growth period; heading up the QA & QC functions will see the appointee as one of the most influential members of the management team.

They will be responsible for the leadership of the site quality functions ensuring the quality, safety and efficacy of medicinal finished products in accordance with GMP and market regulations, providing leadership to develop staff and QMS, in line with corporate vision for the business.

RESPONSIBILITIES

• Lead and develop the Quality team (QA and QC); delivering individuals with the technical capability, drive and influence to achieve quality aspects of the business vision
• Develop annual quality improvement plans and objectives
• Chair monthly site quality meetings using trends and data to review and improve performance
• Provide quality oversight to the OBG Board via the Site Leadership Team, and input to strategic and capital decision-making processes
• Ensure products are manufactured, tested and released in compliance to EU GMP, as applicable by through a robust and effective pharmaceutical quality system.
• Oversight of all regulated activities associated throughout the supply chain applicable to relevant products
• Positively influence the outcome of regulatory and customer audits through leadership of site preparations and effective communications
• Ensure flow of products through the QC laboratory and batch review process to achieve on time delivery to customer
• Provide technical expertise to site in quality system processes eg risk management/RCA/CAPA; ensure quality systems are both compliant and lean to support factory efficiency
• Leadership of critical quality incidents eg customer complaints, deviations, recall
• Coach, mentor and develop staff for site or group programs eg graduate program
• Roles and responsibilities of the Qualified Person as required by article 51 of directive 2001/83/EC and further detailed in Eudralex Volume 4 Annex 16
• Ensuring the batch release process is fit for purpose and satisfies the requirements of Eudralex Volume 4 Annex 16
• Ensuring governance structures across site are suitable to allow for certification of batch manufacture as required by article 51 of directive 2001/83/EC
• Ensuring effective communication of key quality performance indicators to site leadership and site departments to support management of the site
• Conceive, define and deliver Quality related improvements projects
• Any other activity deemed quality related by the Head of Quality

Accountabilities

• Direct reporting line to Group Director of Quality
• In-direct reporting line to the MD
• Roles and responsibilities of the Qualified Person as required by article 51 of directive 2001/83/EC and further detailed in Eudralex Volume 4 Annex 16

Experience/Skills/Education required:

• Eligible to act as a Qualified Person under the provisions of directive 2001/83/EC
• Minimum degree level qualification in relevant life science
• Experience within senior management and leadership roles within a Quality organisation
• Proven leadership capability and skills
• Demonstrated experience in developing strategic/tactical plans as part of Continuous Improvement processes
• Experience acting as prime point of contact for regulatory authorities and partners/clients in quality related matters
• Expert knowledge of current GMP requirements in the EU and US
• Understanding of Lean / Six Sigma
• Good communication skills, and ability to influence and direct others

Key Performance Indicators

• Quality Department internal performance KPIs
• Quality Management Systems performance (CAPA’s, deviations, and complaints)
• Right first time figure at QP certification
• Regulatory Inspection performance
• Customer Audit performance

Behavioural Competencies

Capabilities	Competencies	Behaviours
Quality	Understanding of quality management systemsKnowledge of requirements of applicable GMP and regulatory and legal requirements for manufacture of pharmaceuticals in relevant territories around the worldAbility to identify, assess and communicate issues to a variety of levels within the organisationAbility to lead and direct the root cause assessment of deviationsAbility to communicate clearly and effectively the expectations and principles of a strong quality culture	Excellent attention to detailExcellent interpretation of dataCommunication skills allowing feedback of potential issues to employee at all levels  Ability to lead and influence peers within and across functions
Productivity	Ability to achieve set targetsReact to shifting prioritiesAbility to contribute to setting of priorities Ability to set goals and targets for othersAbility to communicate complex information in a clear and concise manner across a number of mediums (ie verbal, written)	Ability to identify and communicate resource constraints, requirements or deficienciesGoal orientatedFocus under pressureTeam working
Job Knowledge	Ability to undertake a task with known knowledge, using practical and technical skills.Share the knowledge and ability to mentor other team members in the task ahead.	Ability and willingness to learn new skillsAbility to share knowledgeEnthusiasm to grow
Judgement	Ability to make a decision based on knowledge, and understanding.Communicate these decisions to other department’sKnow when to seek adviceKnow when to ‘do and tell’ and know when to consult prior to acting.	Rational application of science to make informed decisionWillingness to make decisionsUnderstanding and appreciation with other department’s decisionsConfidence to justify decisions made
Adherence to policies	Competent to follow all site policies, GMP, H&S rules and report if not followed.	Work at dealing with abnormal deviations, situations, continuous review of required policies and assurance to corrective actions.

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