Director, GCP & QMS Quality Assurance

• Bachelor's degree in life sciences, pharmacy, nursing, or a related scientific discipline (advanced degree preferred but not required)
• 8+ years of experience in Clinical Quality Assurance, Clinical Operations, or a related GxPregulated function
• 5+ years of hands-on experience supporting GCP compliance for clinical trials
• Strong working knowledge of global GCP regulations and familiarity with regulatory submissions (e.g., NDA, MAA) and audit requirements
• Demonstrated experience leading or managing audits (sites, vendors, systems, or processes)
• Prior experience working with CROs and clinical vendors in a sponsor environment
• Experience supporting regulatory inspections and inspection readiness activities

• Fluency in English is essential, and capability in German a distinct advantage.

Our 20-plus years of RNAi experience together with our validated mRNAi GOLD™ platform make us a partner of choice for pharmaceutical companies looking to access the benefits of the siRNA and add this revolutionary modality to their discovery pipeline. As pioneers in the design and development of siRNAs (short interfering RNAs), Silence Therapeutics is advancing a new generation of medicines to potentially address the needs of patients who have limited or inadequate treatment options.

Our mission is to use our technology to create a new generation of therapeutics that can improve patient outcomes and, in the process, build shareholder value.

We are developing a deep pipeline of innovative siRNAs based on our mRNAi GOLD™ platform for diseases with a genetic basis. The depth and versatility of our liver-targeting technology gives us the opportunity to address a wide range of conditions in virtually any therapeutic area. Our wholly owned pipeline is currently focused in three therapeutic areas of high unmet need: hematology, cardiovascular, and rare diseases.

Role Purpose
The Director, Good Clinical Practice (GCP) Quality Assurance will be responsible for leading the Clinical Quality Assurance (QA) function in support of all Silence Therapeutics clinical studies.

This role will manage global Clinical Quality Assurance projects from IND/CTA, throughout clinical development, approval and new marketing approvals plus also be hands-on, tactical ownership of QMS, review study documents and deliver GCP training.

Additionally, the role is accountable for the management, development and execution of the Silence Quality Management System (QMS) including Quality and Compliance activities during the product development life cycle processes and to ensure related practices adhere to market(s) Health Authority regulatory requirements as well as the Silence QMS expectations.

• Provide strategic GCP and clinical quality leadership across drug development programs, ensuring alignment with regulatory requirements and internal standards
• Lead, manage, and mentor Clinical QA staff and external consultants, providing both strategic direction and hands-on guidance
• Partner closely with clinical, regulatory, non-clinical, and quality teams to ensure clinical trials conducted by CROs and vendors are compliant with GCP and company requirements
• Develop and oversee risk-based quality plans, investigator site management programs, and audits of sites, vendors, and key clinical documents (e.g., TMF, CSRs, ICFs, safety reports)
• Serve as the GCP QA Program Lead, managing compliance issues including serious breaches and scientific misconduct across clinical activities
• Lead inspection readiness efforts and serve as Clinical QA Lead during regulatory inspections, including mock inspections and follow-up activities
• Oversee Trial Master File (TMF) compliance and ensure regulatory submission documents (e.g., NDA, MAA) are independently audited
• Manage CAPAs, assess compliance risks, resolve quality issues, and escalate systemic concerns with recommendations to senior leadership
• Develop, implement, and maintain GCP QA systems, SOPs, training programs, and quality metrics (KPIs)
• Act as a GCP subject matter expert, supporting vendor oversight, due diligence activities, contract review, and cross-functional collaboration
• Support Clinical QA budget planning and forecasting, while maintaining up-to-date knowledge of global GCP regulations and industry standards
• Perform additional QA-related responsibilities as needed to support organizational priorities

• Ability to view video display terminal images < 18" away from face for extended period of time - up to four (4) hours at a time.
• Ability to operate a computer keyboard and telephone.
• Ability to sit for extended periods of time - up to four (4) hours at a time.
• Ability to articulate clearly and conduct verbal presentations with large and small audiences.
• Ability to travel via automobile and/or airplane.
• Ability to lift, tug, pull up to fifteen (15) pounds.
• To be considered for this position, you must apply and meet the requirements of this opportunity.

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the on-going needs of the organisation.

Silence Therapeutics is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

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