Overview
Quality Manager, CMC and devices – a rare opportunity in a young clinical-stage company dedicated to transforming patient outcomes in its therapy areas. The role requires a self-confident, ambitious leader to deliver successful development growth while creating something new and ground breaking.
Direct message the job poster from The RFT Group.
This position is responsible for key quality tasks related to products and development/clinical projects. The role is a member of the Quality Team overseeing contract manufacturing (drug and device), vendor qualification and distribution operations, supply chain operations and development functions, as well as the development and maintenance of the company’s quality management system (QMS).
Key Duties and Responsibilities
* Support the development, implementation and maintenance of a robust and compliant QMS for each phase of the Device, Combination Product and Packaging Lifecycle, in alignment with company goals and development plans, and compliant with all relevant regulations.
* Provide quality oversight, guidance and monitoring of internal CMC functions and third-party vendors, setting appropriate Quality standards to be met.
* Ensure appropriate and compliant documentation of all CMC quality activities, e.g., deviation investigations, CAPA reports, post-implementation impact assessments, root cause analyses, risk assessment, change control.
* Review and monitor CAPAs/deviations/product complaints identified internally; review and approve product complaints, deviations, change controls, and lead investigations where required.
* Represent for product and analytical/manufacturing related investigations, root cause analysis, and CAPA development and CAPA review and approval at the respective contract manufacturers, distributors and/or suppliers.
* Collaborate with CMC team and contract manufacturers, packagers and testing laboratories to resolve quality issues and guarantee an uninterrupted supply of drug product and device components to clinical sites.
* Participate in due diligence activities associated with strategic partnerships, supporting technology transfer, process scale-up and process improvement projects as needed.
* Play a lead role in supplier/vendor qualification including conduct or oversight of required audit activities.
* Manage and/or conduct GxP internal audits.
* Review approval and oversight of vendor Quality Technical Agreements and manufacturing documentation such as master batch records, labels and artwork requiring quality approval.
* Evaluate proposed changes to manufacturing and supply chain processes, including conducting quality impact assessments, and authorize these changes, if appropriate.
* Provide quality-related input into GxP supplier/vendor oversight activities and build authentic relationships with critical suppliers and contract manufacturers.
* Represent QA within project teams (internal and with vendors) providing input, strategies, options and process improvements.
* Participate in, review and approve quality risk assessments for products and processes where applicable.
* With Regulatory Team, provide interpretation and application of current and upcoming regulation/guidance in the industry.
* Participate in and lead regulatory inspections of and at contract manufacturers, design houses, packagers and laboratories, as required, including preparation, hosting and management of CAPA plans where required.
* Promote quality and compliance mindset at all levels within the organisation.
Person Spec
* University Degree (e.g., graduate biochemist, biologist, pharmacist, chemist, engineer); preferably with Masters’ level qualification.
* Minimum 5 years’ experience in a quality role in a pharmaceutical and/or biotech company covering areas of CMC and device development and manufacture for clinical supply, QA or QC.
* Extensive knowledge of QA systems in cGMP environments with experience leading GMP audits, including drug product manufacturing and analytical testing sites.
* Experience on quality documentation for inhalation combination products is beneficial but not essential.
* Working knowledge and application of device and combination product regulations, including 21 CFR 820, 2017/745 MDR, ISO 13485, ISO 14971, and ICH Q9.
* Strong interpersonal skills and professional skills to interact readily with internal and external contacts and within cross-functional teams.
* An entrepreneurial, business-oriented mindset with a focus on collaboration, people and the pursuit of excellence, prioritising outcomes for the patient in every decision and action.
* Comfortable working on own initiative and able to perform multiple tasks simultaneously and prioritise workload.
* Flexible, able to adjust, embrace change and a strong fit with the team; willing to “roll their sleeves up.”
Competencies Required for the Role
* Technical Expertise
* Accountability
* Critical Thinking
* Decision Making
* Communication
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Manufacturing, Quality Assurance, and Science
* Industries: Pharmaceutical Manufacturing and Medical Equipment Manufacturing
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