R&D / Tech Dev Product Quality Lead
R&D / Tech Dev Product Quality Lead
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$ 138600 - 257400
1 Vacancy
Job Description
Band
Level 5Job Description Summary
The TRD Project Quality Lead will function as QA Compliance and QA Operations for the life cycle of a product (from development to PPQ/commercialization). This role will interface with all CGT manufacturing/testing sites and be the Quality representative for third party manufacturing and testing sites. This role can function as one or both the sending or receiving site during transfers from the technical development space to early clinical manufacturing or from early clinical manufacturing site to a late phase manufacturing site. This role is responsible for setting the strategy for IND submissions process and analytical changes. The incumbent must be able to lead complex projects and quality initiatives and guide and support global TRD project teams in all qualityrelevant topics questions and issues. Develop project strategies in alignment with TRD considering all relevant crossfunctional aspects to ensure the quality of deliverables within the project. QA representative at expert panel and lead QA aspects of new technology projects; QA representatives for due diligence projects. Will provide QA review and input for questions from Health Authority based upon product filings.Location: East Hanover NJ LIOnsite
Job Description
Key Responsibilities:
- Lead and support global TRD project team and represent TRD QA globally in TRD subteams as well as at global quality board meetings and project development gate meetings.
- Ensure quality oversight on the assigned development projects with strong quality guidance scientific and technical expertise.
- Contribute to the strategy of assigned projects incl. contingency planning and risk assessments as appropriate to ensure timely achievement of project quality deliverables.
- Ensure that the strategy followed within the assigned projects is in line with TRD QA strategies and goals and in compliance to cGMP guidelines and internal procedures.
- Understand and proactively manage the interactions of project related activities between TRD QA and other departments inside or outside of TRD.
- Proactively communicate overall project strategy key issues and any other critical topics in a timely manner to the appropriate management level to the TRD project leader and/or to any other relevant project team member(s).
- Represent TRD QA in Due Diligence teams provide quality assessment of potential inlicensing products in a timely manner and support followup activities as appropriate.
- Provide input to contracts and develop QA agreements with 3rd parties.
- Approve projectspecific QA agreement amendments for assigned projects.
- Lead or participate in global and/or crossfunctional initiatives.
- Coach and mentor functional experts. Participate in recruiting process.
Essential Requirements:
- Bachelors Degree and at least 10 years pharma quality operations OR technical transfer or third party management.
- Fundamental broad understanding and knowledge of quality standards and policies in Drug Substance/Drug Product/Medical Devices manufacturing and control.
- Experience with Health Authority submissions (INDs IMPDs NDAs ANDAs MAAs).
- Broad experience in technical drug development as well as in Quality Assurance and/or Quality Control departments.
- Experience in Technical Operations or equivalent experience from external company is preferred
- Proven track record in successfully leading interdisciplinary teams e.g. scientists working on technical or methodological projects in TRD or equivalent experience from external company or other line function.
- Ability to contribute to matrix teams with the necessary strategic thinking quality awareness and implementation skills.
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $138600 and $257400/year; however while salary ranges are effective from 1/1/25 through 12/31/25 fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further final pay determinations will depend on various factors including but not limited to geographical location experience level knowledge skills and abilities. The total compensation package for this position may also include other elements including a signon bonus restricted stock units and discretionary awards in addition to a full range of medical financial and/or other benefits (including 401(k) eligibility and various paid time off benefits such as vacation sick time and parental leave) dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an atwill position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an email to call 1 (877)and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Range
Skills Desired
Agility Auditing Audit Management Business Partnering Continued Learning Drug Development Employee Performance Evaluations Health Authorities Influencing Skills ISO 9001 Leadership Organizational Savvy People Management Qa (Quality Assurance) Quality Management Quality Management Systems (QMS) Risk Management Root Cause Analysis (RCA) SelfAwareness Stakeholder Management Technological Expertise Vendor ManagementEmployment Type
Full-Time
