Senior Manager BD&L QA (m/w)

Division Global Drug Development
Geschäftseinheit QA GDD
Standort Holzkirchen (near Munich)
Funktionsbereich Quality
Art der Stelle Vollzeit
Anstellungsverhältnis Regular
StellenID 244195BR


Stellenbeschreibung

1. Conducts primary evaluation (where applicable) and confirmatory due diligence to detect quality assurance risks, trends and to identify potential quality and performance issues with in-licensed medicinal products and/or inclusive product portfolio in cases of acquisition.
2. Responsible for all relevant due diligence and integration activities as outlined in the QA assessment procedures.
3. Collaboration with BD&L DD teams to ensure QA involvement in the risk evaluation and timely communication to the business and follow-up on required actions for respective QA area of expertise/focus.
4. Owner of inputs to the overall DD report for assigned QA focus area.
5. Contributes to BD&L Quality Review Boards (QRBs), responsible for collection and reporting of KQIs and status of associated quality remediation/action plan negotiations.
6. Finalize QA due diligence report in collaboration with BD&L QA Partnering Leads as per defined timelines and associated requirements.
7. Follows-up/oversee QA remediation activities and action plans for assigned QA focus area as a member of the respective integration teams.
8. Ensures complete and documented handover to applicable internal QA operations areas following integration activities closure.
9. Reports metrics to BD&L teams and GDQ Management on a quarterly basis and follows-up on concerns and issues until closure.
10. Provides support for internal and external audits and inspections. Ensures inspection readiness at all times.
11. Ensures compliance with regulatory requirements (including record management) and continuous improvement of quality relevant processes within area of responsibility.



Quality


Mindestanforderungen

• Minimum a Bachelor degree in Life Sciences, Pharmacy or Medicine, or other related discipline required.
• Fluent English (oral and written).
• 8+ years working experience in pharmaceutical development and excellent knowledge of the technical development and clinical operations processes and BD&L DD activities.
• Expert knowledge of GCP, GMP, and GVP.
• Sound judgement of which risks and issues are necessary to highlight and properly communicated to (senior) management.
• Excellent interpersonal and communication skills, able to naturally bridge scientific and business participants; track record in enabling effective international collaboration.
• Demonstrated leadership in implementing robust processes and quality systems, and setting global quality standards in a regulated area, including controlled documentation for the pharmaceutical development area.
• Experience in conducting Pharmaceutical QA due diligence.
• Thorough technical understanding and interpretation of regulatory requirements, and Novartis quality standards for comparative assessment of external partners state of quality.
• Demonstrated effective management and establishment of successful international and cross-divisional collaborations.
• Demonstrated root cause analysis skills.
• Ability to work in a global team and matrix structure organization, meet timelines and work with minimal supervision.
• Excellent communication (written and verbal) coupled with excellent interpersonal skills.
• Self-motivated with a high degree of ownership and responsibility for results.

We develop breakthrough treatments and find new ways to deliver them to as many people as possible to improve and extend peoples’ lives. We do this, by supporting and promoting the knowledge and strengths of our employees and specifically use them to deepen our understanding of our patients and customers. Motivating conditions and an attractive salary are also part of our working environment, as well as our company culture, which is based on collaboration, curiosity, enthusiasm, courage and integrity.
Novartis stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.



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