(Only 24h Left) Associate Director QA Evaluation and Integration

Overview
Associate Director QA Evaluation and Integration (QE&I) leads the end-to-end evaluation of In-licensing (BD&L) and Merger/ Acquisition (M&A) up to the integration of the asset into the Novartis network. The role acts as Quality Integration Lead (QIL) to coordinate quality integration of an acquired or in-licensed asset and ensures timely execution of QA activities. The QIL collaborates with QA Line functions, the Quality Integration Team, and the Quality organization at the acquired company or licensing partner, and reports progress to the Quality Integration Office and Integration Governance Boards, including remediation plans typically submitted as Novartis commitments to Health Authorities. The role facilitates timely decision making by QA Management based on input from QA SMEs and business evaluation for the holistic QA assessment covering due diligence evaluation as well as QA integration activities for potential external opportunities.

Major accountabilities

Ensure that Novartis QA and applicable GxP rules (FDA, EMA and other Health Authorities) are embedded in acquired or in-licensed assets.

Set up a Quality Integration Team consisting of QA Line functions, and develop, lead and coordinate quality integration activities from DD QA handover through Integration Planning, Execution and Reporting.

Establish a robust Quality Integration plan with QA Line functions and the Quality Integration Team, and collaborate with the Quality organization at the acquired company or licensing partner. Include risk mitigation measures from Due Diligence and related Quality risk analyses in the Quality Integration Plan.

Ensure that Novartis QA QMS and applicable GxP rules are embedded in the acquired company.

Coordinate and compile data for the Quality Integration Budget for the integration of an acquired or in-licensed asset.

Foster open and effective communication and business partnership with all stakeholders.

Oversee the handover of deals by QA SMEs to the relevant Line Functions and provide QA and technical expertise needed in the Quality Integration process or facilitate SME input where specialist knowledge is required.

Prioritize, resolve issues, and ensure escalation to management.

Establish and lead cross-functional teams and act as single point of contact for BD&L DD QA and support QA assessments for corporate M&A and integration projects as required. Ensure representation of QA SMEs for all necessary functions.

Support comprehensive due diligence assessments across all QA Line Functions and provide timely recommendations to BD&L and M&A.

Represent QA at BD&L due diligence forums as determined by management.

Support Health Authority inspection readiness programs as well as internal/external audits.

Contribute to continuous improvement within the area of responsibility.

Minimum requirements

Graduate in Chemistry, Pharmacy / Biotechnology, Microbiology or another related science or equivalent experience.

Minimum 10 years’ experience in the pharmaceutical industry, including operative experience in QA, Production/Technical Operations/R&D, including at least 5 years in Quality. Demonstrated GxP experience.

Broad understanding of global expectations of health Authorities in GxP regulated areas.

5 or more years of demonstrated leadership and accomplishments in an (international) matrix organization.

Fluent English, written and spoken.

Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. Be a part of this mission and join us in delivering innovative medicines to patients.

Seniority level
Director

Employment type
Full-time

Job function
Quality Assurance

Industries
Pharmaceutical Manufacturing

#J-18808-Ljbffr