External Operations Quality Partner
As a member of the Clinical Supply Quality team, the External Operations Quality Partner is responsible for, but not limited to the QA review of IMP batch records, ensuring the prompt resolution of all batch manufacturing issues and ensuring close out of development related CAPAs. This role provides direct partner driven, pragmatic and proactive support for development manufacturing.
The Responsibilities
- Provide timely and efficient GMP/GDP IMP Release function to all relevant project activities related to the development of the pipeline projects (included all relevant activities for IMP release: label approval, batch record documentation, etc…).
- Support compliance with all relevant and appropriate regulations and guidelines, such as those relating to GMP/GDP, health, and safety, etc.
- Support the systems and processes in place for the appropriate documentation of the company’s development activities and to maintain them in a manner compliant with regulatory and corporate requirements.
- Ensure the Clinical Supply Quality activities are consistent across the range of different environments and teams supported (Vendors / Suppliers / in house).
- Proactively support the activities of Clinical supply for relevant manufacturing quality systems (deviation close out / Change management / complaints / quality improvement).
- Identify and facilitate resolution of technical and manufacturing quality issues that may impact the quality of the CMC sections of regulatory submissions.
- Provide support in the evaluation of Temperature excursions for IMP.
- Management of Quality Complaints of IMP.
- Ensure active participation in the selection, evaluation, approval and maintenance of Vendors for IMP activities, including leadership or support to conduct appropriate audits.
- Oversight of Distribution activities (deviations, Business Review Meetings, assessments, etc…).
- Ensure CMO (packaging and distribution vendors) quality documentation is accurate and up to date, by editing and reviewing quality agreements.
- Contribute the preparation of audits (internal/external, regulatory inspections).
- Lead internal audits / Self-Inspections.
- Ensure that all review and release, manufacturing and packaging operations are appropriately compliant with applicable regulations (EMEA, FDA, DEA, MHRA, etc. where relevant). Support the Head of Clinical Supply Quality in ensuring an acceptable outcome of all audits and inspections, especially those by government agencies, as they pertain to Process Support and Package Development practices (where relevant), equipment, and facilities.
- Actively participate in identifying, developing, and implementing local quality and operational excellence improvements in response to business requirements, technical changes, and regulatory requirements by encouraging others to seek opportunities for different and innovative approaches to addressing problems and developing solutions.
- Ensure Clinical supply Quality processes directly support Technical Operations and development partner goals and objectives.
- Review and QA approval of deviations, change controls and complaints.
The skills and Knowledge Requirements
- Good knowledge of cGMP and relevant regulatory requirements (e.g US, European, Japanese).
- QA/compliance experience in pharmaceutical regulated environment.
- Function effectively with minimal supervision.
- Good teamwork and project management skills. Must have strong, organization and analytical skills.
- Must be fluent in English, other languages are a bonus.
- Facilitator, influencer, and planner.
- Fact based decision maker: understand complex issues and can contribute to informed.
- decision making when working on “grey” issues.
- Able to make/influence quality/compliance decisions in a CMC development environment.
Our Offer
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.
Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
