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Head of Quality
il y a 2 semaines
Precigen ActoBio is advancing an exciting pipeline of novel microbe-based therapeutic products and to further our efforts we are seeking a **Head of Quality **who will be leading and directing the Quality team and will be accountable for defining Quality strategy and execution in clinical development programs. This role will work closely with colleagues in CMC manufacturing and quality control, clinical development and operations, translational research, program leadership, and regulatory.
**DUTIES AND RESPONSIBILITIES**:
- Overall responsibility to maintain and develop the Quality Management System (QMS) and assure GxP (GMP, GCP, GDP and GLP) compliance to support Precigen ActoBio’s clinical pipeline.
- Coordinate gap-identification and areas for improvement of the QMS.
- Lead and oversee all operational QA activities as Head of the GxP Management Committee.
- Coordinate agency inspections and internal/external GxP audits. Evaluate findings, prepare and follow-up of action plans.
- Coordinate the QMS including SOP management, deviations, change controls, CAPA, complaints, OOS, lab investigations, recalls.
- Keep up-to-date of regulations and guidance’s with respect to GxP, legislations, competent authorities and company standards.
- Establish and direct Quality Control (QC) programs and GxP training programs.
- Write, review and approve reports, essential clinical trial documents (e.g. clinical protocol, IB) and other GxP documentation for regulatory submissions/inspections. Guarantee good documentation practices.
- Manage departmental budget for Quality Assurance, including defining materials, equipment and personnel needs.
- Set-up and establish Quality Agreements with third-parties and follow up on the resolution of issues in case these were identified.
- Set-up and manage execution of audit plans of external CMO/CRO vendors involved in CMC, and (pre-)clinical activities.
- Represent the QA department in project team meetings.
**REQUIRED QUALIFICATIONS**:
- Master of Science in Biochemistry/Biotechnology, Industrial
- or Bio-engineering, (Industrial) Pharmaceutical Sciences, or related scientific discipline.
- At least ten (10) years of relevant experience in QA in the pharmaceutical/biotech industry.
**REQUIRED COMPETENCIES**:
- Functional Skills:
- Experience in a GMP/GCP environment. Experience in other GxP areas is an asset.
- Excellent knowledge of the relevant European and US regulations for pharmaceutical products.
- Strong organizational skills, effective organization and implementation of group projects, able to prioritize different tasks and responsibilities.
- Capable of fostering change and innovation in a small and growing organization.
- Ability to think and adapt to a rapidly changing environment and demands.
- Able to reach rational conclusions through complex processing of information.
- Capable of high performance in independent work as well as in a team setting.
- Leadership in empowering team members of the Quality department and GxP team members.
- Technical Skills:
- Proficient in the use and understanding of MS Office (Excel, Word, PowerPoint, Outlook.)
- Experienced in using document and quality managements systems (e.g. Veeva Vault.)
- Soft Skills:
- Excellent communication, reporting and coordination skills.
- Dynamic, flexible, confident, positive attitude, enthusiastic and charismatic.
- Value based collaborator - respectful, accountable and collaborative.
- Strategic and creative thinker.
- Self-motivated and independently minded.
- Problem solving and risk mitigation skills.
- Appreciate of diversity and multiculturalism.
- Ability to build working relations throughout the organization and with business partners to achieve business goals.
- Ability to manage multiple projects in a fast-paced environment.
Precigen ActoBio is a wholly-owned subsidiary of Precigen. (NASDAQ: PGEN).
We invite you to discover more at Precigen ActoBio.
