- BBBH815327 May 10, 2022 Competitive
Our client, a global Biopharmacutical based in North Dublin is looking for a Director of QP operations. This exciting opportunity has come about due to internal progression.
The position will support Finished Drug Product (FDP) certification of biologics for the EU and ROW markets and release of Biologic Drug Substance from Dublin commercial and clinical manufacturing operations.
This role will have accountability for ensuring all release activities are performed in accordance with regulatory and company standards and procedures, and the requirements of the Irish and international regulatory agencies.
The role will also provide strategic leadership at the Dublin site and within the brand teams on all matters pertaining to release of Drug Substance and certification of FDP biologics including but not limited to HA interactions, release strategy, product/financial flow and significant events.
- Lead a team of Qualified Persons and Quality Specialists responsible for release of Drug Substance at the Dublin site and QP certification of commercial biologic products manufactured both internally and externally
- Manage batch certification process in accordance with the EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines (Annex 16) for all commercial DP biologics released to the EU and ROW markets
- Responsible for Drug Substance release and associated processes at the Dublin site
- Represent the release function in internal, corporate, and regulatory inspections
- Collaborate with internal and external manufacturing to support supply of FDP biologics to markets in scope
- Ensure team has appropriate oversight of manufacturing, packing, and testing operations through effective management of quality agreements, change control and site visits as appropriate
- Lead escalation via Notification to Management (NTM) for significant issues discovered as part of certification activities
- Manage relationship across internal and external manufacturing stakeholders and brand teams
- Partner with disposition GPO/GPL and other certification/disposition teams in the network to ensure alignment and best practices for the operation
- Participate in the product recall process and Board of Health notification process
- Identify and recommend product and process quality improvements
- Provide representation, guidance, and leadership in process improvement initiatives globally and locally
- Responsible for hiring, coaching and development of staff
- Provide strategic planning and direct personnel to achieve operational goals and ensure the timely completion of tasks
- Provide adequate resources for QP Operations
Qualifications, Knowledge and Skills Required:
- Degree in Science, Engineering, or related discipline
- Extensive experience in Biopharmaceutical/Pharmaceutical industry acting as a Qualified Person
- Minimum of 5 years' People Leadership experience
- Eligible to act as Qualified Person in accordance with the EU Guide to Good Manufacturing Practice as defined in article 51 of Directive 2001/83/EC
This role offers a hybrid working environment and an extremely competitive salary and benefits package.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
Manager | Engineering Recruitment
+353 21 2300300