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Associate Director, GMP Quality Assurance (m/f/d)
07.03.2023 / Silence Therapeutics GmbH seeks Associate Director, GMP Quality Assurance (m/f/d)
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.
The Associate Director, GMP Quality Assurance will support the development and execution of the Silence 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.
• Implement, maintain and execute Silence QMS.
• Author, implement, train and periodic review of Silence SOPs.
• Review & approve QMS documentation when required.
• Review production batch related documentation and execute technical release per Silence requirements.
• Contribute to Deviation/Investigation resolution in partnership with CMOs.
• Manage QA systems such as Change Control and CAPA.
• Perform GMP audit of service providers including Contract Manufacturers and Testing labs.
• Support Heath Authorities audits, evaluate and follow up on the appropriateness and completeness of corrective action plans until closure.
• Support CMC Team in the compliant delivery of Investigational Medical Product.
• Oversee and support the Veeva Quality Docs and Training modules.
• Participate in development of GMP training program, on job documentation training for CMC personnel and provide on-going GMP training to CMC personnel.
• Support Quality Agreement development with GMP service providers as required by the CMC team.
• Develop audit plan and perform routine audits as per the Silence internal audit program
• Provide monthly KPIs and status reports on projects and compliance initiatives to management.
• Perform other duties as required or necessary
• Provide support during internal and external (HA) audits and ensure all corrective actions are addressed as per designated timelines.
• Support the ongoing delivery of the Veeva platform in delivering the Silence QMS
• Minimum Bachelor of Science in Pharmacy, Chemistry, or other Scientific Disciplines
• Minimum 10 years of GMP Quality Assurance experience in the pharmaceutical, consumer health, or medical device industry.
• Strong attention to detail and documentation review skill set. Competent in training associates, innovate new systems, develop GMP culture for an organisation.
• Strong influencing and communication skills. Courage and resolve to do what’s right.
• Strong communication skills and fluent in English.
• QA and GMP experience in Pharmaceutical and regulatory requirements including auditing and inspection against regulatory / quality standards. Excellent analytical, organizational, and problem-solving skills.
• Good knowledge of computer systems, i.e. Microsoft, Word, Excel & PowerPoint.
• Demonstrated understanding best pharmaceutical industry practices, GMPs, and Quality Assurance and Regulatory.
• Team oriented individual with personal commitment to human relations, integrity, giving and receiving constructive feedback, adaptability, diversity and communication.
• Clear affiliation with our vision and values, and a true ambassador of our organisation.
• Proven ability to effectively prioritise workload and strong organisational skills.
• Strong attention to detail and pride in the quality of their work.
• Excellent written and verbal communication skills.
• Holds a passion for collaborative working, building relationships and excellent stakeholder management experience.
Please send your application to HRGermany@silence-therapeutics.com