MSD Qualified Person Associate Director 

Ireland 

844967122

Job Description

What you will do:

Bring energy, knowledge, innovation, and leadership to carry out the following:

• Perform Qualified Person (QP) duties in certifying batches for release in accordance with the relevant EC Directives including 2001/83/EC, Annex 16 and Annex 13 of the EU Guide to Good Manufacturing Practice and Company Procedures.

• Assure batch manufacturing and testing hasbeen performed in accordance with cGMP and the relevant marketing authorization (MA) or clinical trial authorization, product specification file, legal obligations and/or technical agreement.Manage and/or escalate any potential CGMP and/or other concerns in a timely manner.​

• Provide oversight of deviations (including approval of significant deviations) and laboratory investigations related to drug substance manufacture, testing and those that may present potential effect on product and /or material.

• Confirmchange requests with product impact whichrequire expanded review (e.g., regulatory, stability, testing impact) have been appropriately reviewed, approved and technically closed.

• Provide oversight ensuring all manufacturing, testing, and shipping processes remain in the validated state.

• Review and approve the Annual Product Review for the drug substance and ensure that all variations, deviations, change controls and CAPA’s are included for the period under review.

• Support supplier/material qualification and quality agreements review and approval as required.

• Support customer and supplier complaint process as required.

• Support Quality Risk Management processes as required.

• Support Market Action Response Team as appropriate in batch / product recalls.

• Ensure and promote compliance to regulatory requirements,evaluating site compliance against emerging regulatory trendsand proactively engaging with global regulatory agencies when required.

• Support the preparation and hosting of Health Authority inspections and Divisional GMP Audits.

In order to excel in this role, you will have:

• Expert level of knowledge of relevant GMPs, regulations and current industry trends.

• Communication, decision making, people influencing and project management skills.

• Problem-solving / critical thinking – ability to understand connections between different technical/quality system areas and recognize potential compliance issues.

• Knowledge, experience, and leadership style to lead the site through the planning, strategy build and execution to ensure RFT regulatory approval.

• BSc. degree (or higher) in Biotechnology, Chemistry, Biology or in a relevant discipline.

• Proven track record in delivering operational excellence.

• EU QP Qualification and experience (at least 5 years) of certifying batches for release in accordance with the relevant EC Directives including 2001/83/EC, Annex 16 and Annex 13 of the EU Guide to Good Manufacturing Practice and Company Procedures.

• Experience in the biotech industry is required with specific experience in audit readiness, regulatory agency engagement and ability to gain alignment on strategy with senior leadership.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs,please apply today.

Current Contingent Workers apply

No Travel Required

Not ApplicableNot Indicated

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