Senior Director, Quality Assurance
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.
Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
Due to business growth, we have a brand new and exciting career opportunity for a Senior Director, Quality Assurance based at our site in Nottingham.
Reporting to the Vice President, Quality Assurance, the Senior Director, Quality Assurance will be responsible for providing leadership and functional management to Quality Assurance teams and ensuring Quotient’s adherence to current Good Manufacturing Practices (cGMPs) current Good Clinical Practices (cGCPs), Good Documentation Practices, regulatory requirements, and internal procedures and practices for pharmaceutical development, manufacturing, release activities and clinical studies. This includes management of and technical support for Qualified Persons who conduct certified release of manufactured, assembled or imported Investigational Medicinal Products (IMPs).
You will assure timely completion of internal and supplier audits, serve as the point of contact and host for regulatory inspections, and assure client audits are effectively managed to support the business.
This position also promotes a GMP compliant environment and culture with internal and external stakeholders while ensuring established quality systems are employed and continuously improved.
Main tasks and responsibilities:
- Provide a strong strategic and practical management of the GxP aspects of Quotient’s business and overall quality related activities to ensure continued compliance with required regulatory standards
- Assist with the development of strategic plans for the business, in conjunction with other Quotient Leadership Team members.
- Facilitate an environment that allows employees to succeed in their roles.
- Continuously remain up-to-date with the latest industry changes to regulatory requirements and industry standards. Provide consultancy on GxP quality and compliance related issues internally and to customers.
- Assure successful outcomes of client audits and regulatory inspections by managing the sites compliance status, proactively identifying and working collaboratively to resolve compliance risks, and maintaining an effective Quality Management System.
- Identify, communicate, and escalate quality and compliance risks. Provide direction for and assure appropriate and timely resolution of violations and non-compliances, acting always with an appropriate sense of urgency.
- Assure continued compliance and maintenance of quality systems procedures and any other procedures relevant to the company’s Phase 1 Accreditation.
- Assure that client projects are properly staffed with knowledgeable QA resources who serve as engaged and responsible project team members that contribute to the timely execution of projects, the customer’s satisfaction, and assure regulatory requirements are fulfilled.
- Assure timely issuance, resolution and closure of quality events and CAPAs in response to supplier, manufacturing and/or laboratory discrepancies. Provide QA leadership to assure thorough root cause investigations and effective corrective actions to prevent recurrences.
- Track and trend quality metrics, analyse trends and identify and assure implementation of improvement initiatives. .
- Plan, direct and, as necessary, conduct internal & vendor compliance audits to assure compliance to company policies and procedures. Collaborate with department leaders and/or vendors to identify effective corrective actions that meet regulatory requirements, maintaining organizational agility, minimize risk to quality and supply of products and/or services.
- Plan, direct and, as necessary, conduct external compliance audits of vendors. Assure timely resolution of any identified non-compliances to minimize risk to quality and supply of products and/or services.
- Perform detailed review of policies, procedures, work instructions to assure compliance to standards and efficient and effective practices. Serve as a champion for the effective use of the QMS (training, procedures, quality issues, CAPA) across the site.
- Develop productive, dynamic, professional working relationships with site personnel and colleagues in other global Quality Assurance functions. Provide full and timely QA support to internal and external customers.
- Perform other duties as assigned.
The successful candidate will have a degree in a science subject or non-science subject with relevant experience; advanced degree preferred. You will also have extensive relevant experience in pharmaceutical or related industry.
Other skills and experience required:
- Proven leadership experience with the ability to inspire and motivate
- Strong working knowledge of GxP and quality systems. Must possess strong written and oral communication skills, ability to influence change/be a change agent, and be able to coach, mentor and train others.
- Ability to manage performance of the function across multiple sites and deliver results. Skilled in thinking and acting strategically.
In return, you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.
Our Commitment to Diversity & Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion.
We strive to create a diverse Quotient family by remaining committed to the development of our culture, equality, mindset, diversity & inclusion in the workplace.
As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. All applicants welcome.
If you have any questions or need some support with your application, we’d love to hear from you so contact our friendly team at firstname.lastname@example.org.