Head of Quality

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We have an exciting opportunity for a Head of Quality to join our Senior Leadership Team and to lead our QA and Analytical Service functions whilst collaborating across the business to establish, maintain and improve procedures and quality standards in accordance with UK, European and international GMP regulations.

Are you a clear, logical and objective thinker with excellent communication and interpersonal skills? Do you have experience experience in a similar role, at senior management level in the pharmaceutical industry, leading and managing a QA/QC function.? Are you adaptable and flexible to cope with the changing needs of the responsibilities of the business and the role? If so we want to hear from you!

Custom Pharma Services is an Investors in People Silver accredited workplace where teamwork and support is encouraged, and where every individual is valued and supported to achieve their full potential because if you can, then Custom Can!

Please note, applicants must have the right to work in the UK without requiring sponsorship, we do not hold a sponsorship licence.

About Custom Pharma Services (CPS)

Custom Pharma Services has been located in Brighton, UK since 1979 and is a full-service contract development and manufacturing organisation (CDMO) providing services tailored to your needs, no matter how niche or complex. Custom covers the full spectrum of activities from development through commercial manufacturing for both clinical and commercial use. Specialising in Oral Solid Dosage forms with the ability to handle highly potent drugs and poorly bioavailable compounds Custom really is your one stop resource. With direct access to highly skilled experts offering a partnership approach Custom Pharma Services truly has a molecule first mentality, managing all projects with the end in mind. Custom Can!

What you will be doing;

• Monitoring the quality performance of the business against agreed targets.
• Leading regulatory authority audits and support regulatory submissions.

• Ensuring robust and phase appropriate Quality Management System (QMS) is in place to facilitate the development, manufacture, packaging, storage and distribution of product in a manner compliant with GMP, Customer and Regulatory Requirements.
• Managing the activities of the company's QPs, QA and Analytical Services teams .
• Managing the actions of the Responsible Person, in accordance with Home Office Controlled Drug requirements.
• Ensuring all aspects relating to pharmacovigilance compliance for our own products and specials are managed.
• Liaising as required with clients and their quality and compliance executives to ensure there is a strong relationship of mutual support and customer service.
• Ensuring the presence of adequate Customer Technical Agreements that foster and set up good communication with customer Quality Departments to ensure agreement and clarity on service level expectations and responsibilities over quality standards.
• Managing, maintaining and improving the QMS to ensure it is current, meets and preferably exceeds statutory, industry and stakeholder expectations and embodies risk management principles throughout.
• Managing and developing the quality team, ensuring their effectiveness and professional growth.
• Representing the business with MHRA, international regulatory bodies and the UK Home Office.
• Agreeing, managing and delivering financial performance to meet annual budgets for Quality department.

We are looking for candidates who have experience in;

• Staff management and team building experience, including effectively managing and developing people.

• Product formulation, development and clinical supply (IMP).
• Meeting Regulatory Compliance standards for the EU, US and other international markets.
• The delivery of key objectives.
• Strategic planning and budgeting.
• Implementing quality assurance systems in a GMP/GCP/GLP/GDP/IMP environment.
• Lean and Six Sigma, process & operational process improvements.

We are looking for candidates who;

• Build and maintain good working relationships, both internally and externally working across multi-disciplinary teams.
• Have strong presentation skills with the ability to present credibly to clients and colleagues.
• Have the ability to critically evaluate and troubleshoot complex problems.

Our benefits package includes:

• Rising holiday allowance to 26 days holiday plus UK bank holidays
• Group personal pension scheme
• Annual profit related company and individual bonus payment based on successful performance
• Life assurance at twice annual salary
• Health Plan with Simply Health including access to a GP or Counselling Services 24/7, money back on prescriptions, optical, dental and physiotherapy
• Ride to work scheme
• Subsidised Gym Membership
• Discount Shopping Portal
• Enhanced Maternity / Paternity Pay
• Employee Referral Scheme bonus of £1,000
• Values based awards
• Free hot drinks vending

Successful candidates will be required to complete a basic disclosure check.

Strictly no agencies please.