Senior Director of Quality

Do you enjoy developing systems and processes from the ground up?

Are you someone who is passionate about culture, drive, and innovation?

Fraser Dove International is partnering exclusively with a technology organisation specialising in broadening access to complex medicines. Operating out of Canada, they are committed to protecting biopharmaceutical supply chains against disruption.

Our client is seeking a Site Head of Quality leader who is dedicated to quality excellence, innovation and the advance of complex medicine manufacturing to support patients worldwide.

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

Your objectives:

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

1) Cultural transformation and Business improvement.

2) Effective leadership, driving innovation and results.

3) As part of the leadership team, pivotal in driving set strategic goals.

What you will do:

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

Overseeing the GMP operations at the manufacturing plant and ensure adherence to applicable laws and regulations, corporate policies/standards, and client requirements.
Be accountable for site processes and procedures in order to successfully fulfill the responsibilities for Quality Assurance, Quality Control, Quality Systems and Compliance.
Recruit talent and build a high performing Quality team, as well as mentor and develop employees and ensure the team’s agility, versatility and expertise redundancy.
Collaborate with other Quality leaders and enterprise stakeholders and assist in the implementation, continuous improvement and lifecycle management of GMP policies, standards and quality management systems.
Govern and/or contribute to the development and execution of Quality Agreements with clients; be accountable for the timely and compliant delivery of site’s responsibilities in accordance with the Quality Agreement requirements.
Provide timely communication and product disposition to clients; i.e. assure timely notification, investigation and mitigation of quality events.
Be accountable for timely notification and effective management of internal and client-related changes.
Lead site audit and regulatory inspection readiness plan; manage and host client audits and regulatory inspections and ensure timely and compliant responses and resolution of identified deficiencies.
Effectively manage the site’s GMP training program. Champions initiatives for continued learning and development.
Represent site Quality in corporate planning and joint Client- forums, as applicable.
Prepare and host periodic site Quality Management Reviews to assess the health of the Quality Systems and collaborates with stakeholders to ensure identified improvements.
Contribute to the periodic Corporate Quality Management Review and ensures a harmonized implementation of risk mitigation initiatives.
Develop and manage departmental goals and corresponding budget in alignment with corporate vision and goals.

What you will bring:

These are the skills and experience you will need to succeed as the Senior Director of Quality:
Comprehensive knowledge of global GMP regulatory requirements for biologics and vaccine products.
Hands-on experience with overseeing GMP operations at a biologics or vaccines manufacturing plan is required, as well as multi-phase and multi-modality operations.
Multi-phase and multi-modality operations.
Facility commissioning and qualification.
Managing regulatory agency inspections.
Proven record with building high performing Quality teams.
Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward.
Demonstrated ability to perform long-term project planning, team building, budgeting, and operational excellence.
Successfully executed responsibilities in a fast-paced environment, collaborating across corporate functions and multiple stakeholders.
Excellent oral and written communication skills.

What you will get

These are the perks and benefits that will complement your generous base salary:

Annual bonus
Relocation assistance

Got what it takes?

To apply for the Senior Director of Quality click the ‘Apply’ button below or contact the Executive Search Consultant – Kaitlin Francis – on +44 (0)203 355 7050.

Please Note:

· This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments.

· If you have not heard from an Executive Search Consultant within ten working days from the date of your application, please consider yourself unsuccessful on this occasion.

· We use the information in your application to support your job search, contact you with relevant opportunities and to improve our services. For more information on how we process your personal data, please view our Privacy Policy available on our website: https://www.fraserdove.com/privacy-policy/

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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.

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Senior director of quality