Associate Director Research Quality
Associate Director Research Quality
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$ 145000 - 270400
1 Vacancy
Job Description
Job Description Summary
This position will be located at San Diego site and will not have the ability to be located remotely. This position will require minimal travel as defined by the business (domestic and/ or international).The Associate Director Research Quality is responsible for the development implementation and management of the quality program applicable to the wide range of discovery science and scientific research activities conducted within NIBR globally.
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Key Responsibilities:
This role will be responsible for this role in Research Quality (RQA):
1. Establish research quality standard & compliance monitoring program focusing on internal customer satisfaction and sustained compliance to data quality & integrity standards policies for Human Tissue use data privacy and regulatory requirements. Establish a continuous improvement program.
2. Lead evaluation for monitoring the performance of the existing Research & Lab processes and systems for the identification of potential quality and Data Integrity gaps. Work effectively in a matrix environment to develop propose and implement processes across BR to ensure good data management and sustained compliance.
3. Lead/supervise/participate in the review of research and laboratory project documentation (e.g. Lab notebooks and systems) for both internal processes and external collaborators to assess for Data Quality & Integrity. Provide BR Quality management with reports on the results of the reviews. and support issue resolution and closure.
4. Maintain an awareness of quality issues that impact scientific and business objectives. Interact with internal and external departments to provide interpretation of Quality & Compliance information to meet business and regulatory requirements and provide an understanding of how aspects of external requirements may impact the BR organization.
5. Collaborate with BR business partners to support the development of scientific discoveries & research innovation utilizing risk based and mitigation quality processes.
6. Lead and support Quality Due Diligence for Business Development and Licensing Agreements. Review the Quality of the preclinical data for potential assets in the due diligence process and make recommendations to the greater Due Diligence Team.
7. Review industry trends for GxP and nonGxP regulated areas applicable to the NIBR Research areas and recommend appropriate and timely action.
8. In coordination with the Training department and internal customer needs ensure the required Data quality & Integrity training is established. Establish report and monitor KPIs related to the program for continuous improvement.
9. Promote a robust quality culture across NonGxP research & Lab. Train and educate scientists and other QA associates in Data Quality & integrity and quality system requirements in terms of its content delivery and strategic importance.
10. Provide expert knowledge in the use of Human Tissue samples in research and have the ability to interpret and provide guidance on country specific regulations. Work in a matrix environment with Legal and Data Privacy to implement the relevant practices.
Job Description
Requirements:
- Ph.D. in a Scientific and/or Engineering discipline preferred and/or related equivalent experience.
- Demonstrated experience in a senior Compliance and Quality System role.
- 10 years broad experience in a scientific/pharmaceutical industry. Experience in a Biomedical research environment is considered a plus.
- Strong strategic vision and superior leadership experience including excellent communication collaboration/consensus building influencing and negotiation skills
- Demonstrated ability to partake or lead crossfunctional projects and to effectuate change within a highperforming organization.
- Experience in coordinating/integrating with a wide range of business functions and success working globally in multidisciplinary teams.
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $145000 and $270400/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.
Company will not sponsor visas for this position.
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
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 sex national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status.
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 to perform the essential functions of a position please send an email to or calland let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$145600.00 $270400.00Skills 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 ManagementRequired Experience:
Director
Employment Type
Full-Time
