Senior Director, Compliance
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 growth and expansion, we have an exciting opportunity for a Senior Director, Compliance to work within our Candidate Development business unit. In this role, you will be responsible for ensuring our compliance activities (Quality Assurance, Regulatory Affairs, EHS and Compliance) are delivered in accordance with current regulations, standards, company policies and procedures.
Providing leadership and functional management to and driving excellence in execution within each of the areas, collaborating cross-functionally to promote a compliant environment with relevant stakeholders and driving continuous improvement programs and fostering the compliance culture across the business unit.
Main tasks and responsibilities:
- Provide a strong strategic and practical management of the compliance aspects of the Candidate Development Business Unit and ensure continued adherence with required regulatory and statutory requirements.
- Collaborate with the UK regional heads of Regulatory Affairs and EHS to support effective execution of functional responsibilities for the Business Unit. Develop productive, dynamic, professional working relationships with personnel and colleagues in the Business Unit and across other Business Units.
- As a Quotient senior manager assist with the development of strategic plans for the Business Unit, in conjunction with other leadership team members.
- Establish annual function objectives that align with Business Unit and global QA objectives. Generate individual objectives that are SMART (Specific, Measurable, Attainable, Realistic, Time-bound) and assure successful achievement of function objectives.
- Mentor, coach, support and develop QA, RA and EHS colleagues and encourage continued professional development. Conduct communication and feedback sessions through team meetings and one-on-one interactions to assure appropriate direction, feedback and coaching for success. Develop robust succession plans for the team.
- 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 site’s compliance status, proactively identifying and working collaboratively to resolve compliance risks, and maintaining an effective Quality Management System. Serve as audit host for regulatory inspections. As required, lead the resolution of and response to any audit/inspection findings. Effectively communicate audit and inspection outcomes to site and Executive Management.
- 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 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.
- Ensure QP/QA oversight, review and approval of master and executed batch records, protocols, reports, and investigations. Maintain ownership for the Site Master File and Site Master Validation Plan. Oversee lot disposition and release activities for drug substances and products within established timeframes to meet commitments to clients.
- Assure timely issuance, resolution and closure of quality events and CAPAs. Provide leadership to assure thorough root cause investigations and effective corrective actions to prevent recurrences.
- Track and trend compliance metrics, analyze trends and identify and assure implementation of improvement initiatives. Assure metrics are reported to site and global management.
- Plan, direct and, as necessary, conduct internal and vendor compliance audits to assure compliance to company policies and procedures. Assure timely resolution of any identified non-compliances to minimize risk and the potential for recurrence.
- Perform other duties as assigned
The successful candidate will have strong leadership skills to guide change in workplace culture and participate in activities taking place throughout our global organization. The candidate must be a hands-on, participative manager who will lead by example and develop an internal team.
Essential skills and experience required for the role:
- BSc or equivalent in a relevant scientific subject; advanced degree or Qualified Person status desirable/preferred.
- Extensive relevant experience in pharmaceutical or related industry. Relevant line management experience.
- Extensive knowledge of GxP regulations and quality systems. Understanding of CMC regulatory documentation and workplace and environment safety.
- 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.
- Demonstrated skill 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.