Senior Director Compliance (QA, EHS, RA,)

Our client is a leader within drug development and manufacturing accelerator and provide various tailored services across the full scope of the development pathway.
A recent organisational and expansive restructure has seen an exciting new opening for a Senior Compliance director to join the business working within their candidate development unit. You will be responsible for delivering compliance activities (Quality Assurance, Regulatory Affairs, EHS and Compliance) are delivered in accordance with current regulations, standards, company policies and procedures.
The role:

* Provide a strong strategic and practical management of the compliance aspects of the Candidate Development Business Unit as well as 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 candidate development unit.
* As a senior manager assist with the development of strategic plans for the Business Unit, in conjunction with other senior team members.
* Establish annual function objectives that align with Business Unit and global QA objectives.
* Mentor, coach, support and develop Quality, RA and EHS colleagues and encourage CPD (continued professional development).
* Continuously remain up–to–date with the latest industry changes to regulatory requirements and industry standards. Provide expertise 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.Serve as audit host for regulatory inspections.As required, lead the resolution of and response to any audit/inspection findings report on inspection and audit outcomes to Exec 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.
* 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.
* 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.
The Person:
The successful candidate will have strong leadership and development skills and will be a hands on quality professional .
Essential skills and experience required for the role:

* BSc or equivalent in a relevant scientific subject; advanced degree. QP status a bonus
* Extensive relevant experience in pharmaceutical or related industry ideally with experience within drug substance.
* 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.
* Experience with development of teams within a QA function.
For more information or to speak about other opportunities please contact Sheldon Grant at CPL Lifesciences on [](mailto:)