Head of Quality Assurance - Abingdon, United Kingdom - Aptuit part of Evotec

Description

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Are you an experienced Head of Quality Assurance? We are looking for a truly skilled empathic leader to head our Quality Assurance UK Team.

You will be a skilled influencer with highly tuned attention to detail, who is looking to be part of transforming the quality team in the UK into something genuinely special? If you are working within pharmaceutical, life sciences, or _
Research_
Services (CRO) with GMP knowledge (regulations MHRA, Eudralex and FDA)_ _
Do you want to influence and be part of the global quality team? If so, then this could be an opportunity for you_


Role:
Head of Quality Assurance, Permanent.


Direct report:
Head of Global Drug Development Quality Assurance


Hours:
Full-time, 40 hours per week, Monday to Friday, Days only.


Salary:
starting from £75,000pa, dependant on qualifications and experiences, plus we offer a fantastic benefits package and annual bonuses.


Location:
Milton Park, Abingdon, Oxfordshire, OX14 4RZ.


Our Company

Evotec, Aptuit's parent company, is a leader in the discovery and development of novel therapeutics of all modalities with operational sites in the UK, Europe (Germany, Italy and France) as well as the US.

Aptuit Oxford provides integrated Chemistry, Manufacturing and Control capabilities to fully support drug substance development and GMP manufacturing on both laboratory and commercial scales for Active Pharmaceutical Ingredients.

An exciting opportunity has arisen to join our dynamic quality specialist team. You will be working with a high-performing and friendly team.


Role and Responsibilities for our Head of Quality Assurance

As our Head of QA and to efficiently support the continued growth of our API manufacturing site on Milton Park, near Abingdon in Oxfordshire, The Head of Quality Assurance is a senior managerial role within the Quality Unit department reporting to the Head of Global Drug Development Quality Assurance.

In this role he/she will lead the QA team to guarantee GMP compliance aspects related to company business and compliance.

This role initially will be based on site to meet and get to know the team and business, moving to a flexible hybrid on-site role to meet the business and compliance needs.

Key Responsibilities

• Providing Leadership for the UK Quality Assurance (QA) department to ensure compliance consistently to high standards.
• Driving Quality Assurance with Continuous Improvement techniques throughout the organisation.
• Ensure Evotec's global QA policies and initiatives are implemented at the Oxford site.
• Ensure QA personnel are trained and knowledgeable to perform their assigned job description.
• Ensure all activities within the QA department are in line with Evotec policy, and is cGMP compliant at all times.
• Monitor Quality KPIs for the site and provide trends to Site Quality Council (SQC) and relevant corporate management.
• Drive improvements in site KPI's from adverse trends reported in SQC.
• Consult all departments to ensure their compliance to Evotec policy, best practice and cGMP.
• Lead initiatives to drive improvements in the standards of cGMP and quality culture across the sites.
• Produce results in line with Evotec policy, best practice and cGMP in the desired timeframes as directed by the business and by their line manager.
• Leading change and risk management activities for Quality.
• Quality Assurance Representative within the UK Site Leadership.
• Perform cGMP and Quality related intra

- and inter-departmental training and on-boarding of new staff members across site.

• Oversee both internal and external audits to ensure Evotec Quality policy is upheld.

Skills & Competencies

• Highly influential leader with the ability to forge strong and lasting relationships, and an approachable nature who can really support and develop within the team.
• An excellent awareness of cGMP procedures and API Manufacturing, within both the QA Department and other areas of the business
• Lead complex projects with crosssite and crossdiscipline activities to ensure the business continues to operate to cGMP
• Excellent interpersonal and communication skills, including remote interactions, as well as good organisational and time management abilities.
• Comfortable with interactions with the leadership team internal and external stakeholders on all matters of Quality and inspire trust and confidence.
• Strong attention to detail and excellent data capture and analysis standards as well as written and oral presentation skills.
• Problemsolver with a strong ability to implement new ideas and best practices.
• Highly adaptive and able to work effectively in a fastmoving and highgrowth environment.
• Ability to drive change by providing clear plans and objectives for the team and key stakeholders.
• A natural enjoyment of working with people, highly empathetic and connecting with those that do the job along with their leadership.
• Enthusiastic and flexible, positive