Senior Director, Site Head of Quality

Senior Director, Site Head of Quality

Have you improved / implemented quality management systems, standards and procedures?

Do you have exposure to different international cultures?

Have you got strong experience with FDA and EMA?

Fraser Dove International is partnering exclusively with a leading Pharmaceutical organisation. Operating globally, they are committed to ensuring that everyday health remains affordable.

Our client is seeking a strong leader to lead and manage quality units on the company’s site.

Discover more about our Senior Director, Site Head of Quality opportunity; its objectives, duties / responsibilities and the skills, experience and competencies needed to succeed.

Your objectives :

As the Senior Director, Site Head of Quality, you will be measured against the following objectives :

1) Leading and managing site quality units.

2) Setting and implementing quality standards and ensuring compliance with any relevant guidelines.

3) Guaranteeing on-time product delivery, meeting pre-defined quality standards, within resource and cost targets.

What you will do :

As the Senior Director, Site Head of Quality, your duties and responsibilities will include :

• Responsible for the site’s Quality strategy.
• Continuously assessing Quality processes and systems as well as the regulatory compliance status of products, to proactively identify compliance risks.
• Ensuring the site Quality Management System is efficient and aligned with company standards, local and global regulations.
• Collaborating with corporate quality functions to ensure site compliance with the company’s Quality Management Systems (QMS).
• Periodically reviewing the site QMS, identifying gaps, developing mitigation plans and ensuring implementation of upgrades.
• Ensuring that site and products (medicinal products, food supplements, medical devices and cosmetics) comply with all relevant regulations (GxP, ISO, HACCP) applicable to each product category manufactured
• Communicating significant quality or regulatory issues and risks that may impact product quality or regulatory compliance to the site leadership team and the Regional Quality Head in a timely manner.
• Collaborating with internal business partners on mitigation plans, ensuring adequate resourcing and execution of plans.
• Responsibility for the QC laboratory.
• Ensuring analytical methods used for starting materials, in-process controls and finished product controls are validated and comply with regulatory requirements.
• Ensuring that adequate cleaning validation is in place to avoid cross contamination.
• Supporting analytical method transfers.
• Ensuring OOX results are thoroughly investigated in a timely manner.
• Ensuring timely batch disposition of products manufactured at the site as well as supplied by CMOs, based on local regulations and in alignment with local Planning and global Supply Chain prioritizations.
• Proactively preparing for and managing Health Authority inspections and customer audits by ensuring the site is operating in an “inspection ready” manner at all times.
• Preparing adequate and timely responses to any inspection observations, identifying appropriate and thorough corrective and preventive actions and ensuring CAPAs will be implemented on time.
• Ensuring that source materials used for production of the drug products comply with quality-, product-specific and legal requirements.
• Ensuring that all suppliers of GMP materials are initially qualified and will be requalified on a routine basis.
• Organizing periodic Site Quality Councils and reviewing process performance, product quality and quality management system efficiency, as well as site quality metrics, and advocates continuous improvement projects.
• Actively monitoring product metrics and initiating / supporting improvement projects to enhance performance.
• Cooperating with quality organizations across sites.
• Individual with strong leadership and communication skills and the ability to create a highly capable, engaged and motivated Site Quality Leadership team.
• Developing the Site Quality Leadership team thorough succession planning, talent management and individual development plans.
• Attracting, developing, and retaining a high performing team to meet the current and evolving needs of the business through effective selection, training, and development, coaching and mentoring and performance management.
• Developing and implementing annual goals for the direct reports in alignment with the Regional Quality Head and aligned to the site goals, monitoring target achievement and performing the annual performance review for the direct reports.
• Ensuring a robust Training System, covering initial and ongoing GMP and SOP trainings, is in place and its execution monitored throughout the site.
• Communicating site quality performance and any need for improvement, to the site leadership team and Regional Quality Head.
• Driving process improvements by applying recognized quality tools, internal audit programs, appropriate CAPA systems and feedback systems (complaints etc).
• Participating in global projects and ensuring timely implementation at the site.
• Establishing the annual budget for the site quality organization to assure availability of sufficient resources to meet site targets.
• Continuously monitoring cost centers to assure alignment with approved budget.

What you will bring :

These are the skills and experience you will need to succeed as the Senior Director, Site Head of Quality :

Got what it takes?

To apply for the Senior Director, Site Head of Quality, click the ‘Apply’ button below or contact the Executive Search Consultant – Peter Vedde – on 44 (0)203 355 7050.

Please Note :

Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives.