Reports to: Chief Executive Officer (CEO)
Direct Reports: 4-6 initially, expanding
MAIN PURPOSE OF JOB
As the Director of the Quality section you will be a pivotal member of the leadership team at Evox. You will define, develop, deliver, and maintain our Quality and Compliance strategy. You will be responsible for developing Quality/Regulatory policies and strategies with CMC, Clinical and Research and implementing them within the company. You will ensure the Company’s Quality System is in compliance with all relevant regulations and standards set forth by regulatory, quality and/or accrediting agencies. The Director – Quality is also responsible for the development of regulatory submissions, dealing with any compliance-related matter internally or externally, e.g. CRO’s and CMO’s You will lead the Quality section (QA and QC) and provide Quality and Compliance oversight to projects and functional groups to ensure outcomes are achieved, advancing the development of Evox’s platform and pipeline.
- Lead, build, establish and maintain Evox’s Quality Management System, covering Research and Development through to GxP activities underpinning Evox’s operations.
- Role model the Company values and leadership behaviours, cultivating high performing and highly engaged teams.
- Ensure implementation of Policies and Standard Operating Procedures for all aspects of GxP operations and GxP supporting systems, in collaboration with the relevant process owners.
- Work collaboratively across internal departments and external partners and guide all parts of the organization on Quality Systems and regulatory compliance in areas.
- Identify areas of potential regulatory compliance risk in research and development, manufacturing and drive the development of programs to relieve potential risk.
- Interact with Regulatory Agencies to ensure that quality systems are adequate, and facilities are compliant.
- Oversee the development and maintenance of Quality Systems both in-house and have Quality oversight of contract manufacturers and raw materials suppliers.
- Maintain and continuously improve systems for document management, training, auditing, vendor qualification, CAPA, deviations, change control, drug substance and drug product release, stability data review and trending, and quality metrics tracking and reporting.
- Monitor the development, manufacturing, and Quality processes to ensure conformance and compliance with applicable regulations and monitor compliance within the company.
- Accountable for the GMP supplier qualification and GMP auditing programs, QA reviews, approvals of master batch records and executed batch records, QA review and approval of stability data.
- Responsible for drug substance and drug product QA disposition, working with QP’s as required.
- Responsible for the overall resource planning and allocation of people to projects from the Quality section to ensure delivery of corporate goals.
- Build strong working relationships with enabling functions, including Finance, IP, Legal, Business Development and HR to ensure the optimal environment for delivery within the Quality Section.
- As part of the leadership team will be responsible for developing skills and expertise within the Company and creating and embedding a culture with Quality at its core, which nurtures talent, thrives on innovation and empowers people to grow and perform at work.
- Present regularly to the internal senior leadership team and provide timely provision of key performance indicator data and review of documentation to support regulatory submissions.
- Proven leader, who has experience of operational and strategic leadership and development of teams.
- Ability to work with the management team and regulatory authorities to meet corporate goals and initiatives while dealing with a developing regulatory environment.
- Will have an entrepreneurial attitude and able to work in a fast paced and agile environment, self-motivated with a high level of attention to detail.
- Strong influencing skills: proven ability to get things done.
- Excellent interpersonal, presentation, written and verbal communication skills.
- Must be a highly motivated self-starter and show initiative; however, also must be attentive to detail and strongly adhere to quality and regulatory mandates.
Experience & knowledge
- Proven leadership experience in the biotechnology or pharmaceutical industry with demonstrated in-depth experience. Typically, >12+ years directly in Quality Assurance/Compliance in biopharma, biologics and/or cell and gene therapy.
- QP status is highly desirable but not essential.
- Demonstrated ability to lead a group of Quality Assurance and Quality Control professionals.
- Extensive knowledge of EU GMP and FDA regulations as well as ICH, EP, USP etc guidelines from preclinical through clinical development and ideally commercialization.
- Demonstrated knowledge and direct experience with developing and establishing Quality Systems and GxP compliance within biopharma/biologics and/or cell and gene therapies.
- Experience of implementing and using electronic quality systems to monitor, report, and track quality tasks and key quality performance indicators.
- Significant experience working with development, manufacturing, analytical, and Quality Control to ensure products are delivered on time and within specification.
- Keeps abreast of all relevant regulatory publications and guidance documents
- Experience supporting and managing EU, US, and/or RoW regulatory inspections.
- Professional and scientific interface established within both professional societies and particularly with the MHRA/EU/FDA/other governmental entities.
- Experience leading internal and external drug substance, drug product and finished pharmaceutical dosage form manufacturing facility audit teams, auditing certification preferred.
- Excellent communication and interpersonal skills for effectively interfacing with internal and external personnel at all levels
- Excellent written and verbal communication skills.
KEY BEHAVIOURAL ATTRIBUTES – ALL STAFF
People with Purpose – We are innovative and creative in the way we work and deliver. We treat each other with respect and dignity and work collaboratively to learn from each other’s strengths.
Driven to Deliver – We strive to deliver our objectives, and then look for our next challenge. We recognise our achievements and celebrate our successes.
Agile and Accountable – We respond to challenges impacting our progress and find creative and innovative solutions to overcome obstacles. We are brave and not afraid to change our approach to achieve a positive outcome in optimum time.
Candid and Constructive – We communicate with honesty and transparency throughout the team. We value giving and receiving constructive feedback to each other and our partners.