Regulatory Compliance Lead
The QMS Manager implements quality principles and mindsets across the Regulatory Affairs function in line with legislative and Regulatory expectations; driving compliance across related activities.
They will train members of the team and collaborate with functional group heads to ensure timely and effective communication, including escalation of any concerns to other members of the Senior Management team.
The QMS Manager will be expected to lead by example, being professional and diligent. They will be responsible for reporting back as needed to the cross-functional Senior Management Team within Diamond Pharma Services group.
Working in a consultancy is a demanding and rewarding role where no two days are the same and as such the applicant should be flexible, willing to work under pressure and able to provide assistance to other team members to ensure the company delivers against its objectives.
General Responsibilities and Duties of the Dept
Diamond BioPharm Limited is the Regulatory function within Diamond Pharma Services. The function provides end to end regulatory services and expertise driven product development advice from early stages of development through to post market support. Our regulatory division are experts in all aspects of European regulatory affairs providing support to clients in the following areas:
- Writing product development plans and providing gap analysis
- IMPD/IND writing
- Technical CMC support
- Preparing orphan applications, PIPs and PRIME submissions
- Assisting with scientific advice procedures
- Clinical Trial Application submissions
- GMO applications
- Ethics submissions
- Assistance in preparing and submitting variations and Marketing Authorisation Applications through the various Regulatory Authority procedures
- Acting as an overflow Regulatory Department
Key Responsibilities and Duties of the Role
- Develop and implement the processes and systems necessary to ensure that Diamond BioPharm Limited will meet both the current and future legislation requirements associated with providing a compliant Regulatory service.
- Embed and maintain a quality culture within the department.
- Ensure consistent quality and standards are upheld within the Regulatory department.
- Evolve and maintain the Regulatory change management process.
- QMS Owner – perform periodic reviews and maintain oversight of the Diamond BioPharm Limited QMS.
- Prepare, lead and support regulatory inspections and vendor audits
- To lead the quality function by helping to identify, and oversee the process for handling change, non-conformities, breaches, complaints and ensuring appropriate corrective and preventative actions.
- To perform impact assessment for all investigations and to establish plans for continual improvement of the QMS and related compliance programmes.
- Establish and maintain the Diamond BioPharm Limited Business Continuity Plan (BCP).
- Lead the implementation of the General Data Protection Regulation (GDPR) within Diamond BioPharm Limited
- Liaise with the QMS manager in Diamond PV Services Limited and the QPs with Diamond Compliance Limited for any relevant cross-functional activities.
- Act as the Quality liaison between Diamond BioPharm Limited and the Client.
- Manage, train and mentor Regulatory staff within the Company for quality system related aspects.
- Compilation and presentation of quality metrics.
- Maintain an awareness of current legislation associated with Regulatory Affairs requirements and ensure that other members of the company are informed and trained as necessary.
- Bachelor’s Degree or equivalent in related science field
- In depth experience establishing/evolving Quality Management Systems (Pharmaceutical field)
- Familiarity with ICH Q10, ISO 9001, PDCA Cycle
- Excellent working knowledge of international GxP ideally including ABPI and IPHA
- Good working knowledge of MHRA regulatory QMS expectations
- Previous experience with preparation, scheduling, carrying out audits of third parties
- Previous experience of leading inspections/audits from health authorities/third parties.
- A professional qualification in Quality and/or Process improvement would be advantageous (CQI, CQA, IRCA, ISO)
- Experience in interpreting pharmaceutical and other related legislation, and ensuring these are put into practice
- Line management experience
- Leadership - to implement, motivate and drive a quality ethos and principles within the company.
- Attention to detail - to identify, investigate, assess and manage compliance risks.
- Decision making - to demonstrate good and appropriate judgement.
- Pragmatic – ability to judge level of detail required
- Interpersonal skills - to mentor and train team members appropriately and effectively.
- Communication skills - strong verbal and written communication skills.
- Time management - the ability to multi-task efficiently.
- Should be dedicated to evolving a career in managing, maintaining and improving quality management systems