Assoc Dir, GLP/GCLP Laboratory Quality

　　Job ID

　　390661BR

　　Jan 23, 2024

　　USA

　　About the Role

　　Location: #Cambridge, MA

　　This position is responsible for overseeing the Preclinical and Bioanalytical QA program to assure compliance to Novartis, and applicable regulations. This position will collaborate and develop strong relationships with internal and external stakeholders and partners to ensure the appropriate processes, systems, and activities are in place to evaluate risks, ensure appropriate mitigation of gaps and ensure high quality execution of GxP lab studies.

　　The role will also be responsible for inspection activities, including interaction with regulatory agencies.

　　Key Responsibilities:

　　•Lead evaluation of internal and external GLP/GCP laboratories QA oversight of processes across BR for the identification of risks and potential gaps to Novartis and/or regulatory requirements. Work effectively in a matrix environment with stakeholders to prioritize, develop, and implement plans to address these gaps and ensure sustained compliance.

　　•Interact with internal and external functions to support implementation of activities from regulatory intelligence that impact the BR organization.

　　•Establish quality oversight program for audit actions/deviations/incident management pertinent to BR GLP/GCP laboratory activities. Ensure implementation of effective KQIs. Pro-actively reviewing outcomes/trends to sustain improvement and ensuring timely escalation when required.

　　•Lead GLP/GCLP inspections and assist in the surveillance inspections as assigned. Interact as required with regulatory agencies regarding GLP/GCLP matters.

　　•Attend and present at the BR Quality Review Board and represent BR Quality on global compliance committees as assigned.

　　•Prepare and ensure execution of the audit plan of internal GLP/GCLP activities, facilities and computerized systems including Report Amendment Audits.

　　•Establish, lead, and implement GLP/GCLP regulatory training program(s).

　　•Support the creation or revision of BR Quality SOPs.

　　•Support the preparation of the annual third party GLP/GCLP laboratory audits and monitoring plan in collaboration with Third Party Management QA oversight.

　　•Support/lead audits and inspections follow-up activities including CAPA preparation, review, effectiveness and closeout activities.

　　•Participate/lead internal projects and contribute to the implementation of continuous improvements.

　　Diversity & Inclusion / EEO

　　We are Equal Opportunity Employers and take pride in maintaining a diverse environment. 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 are committed to building diverse teams, representative of the patients and communities we serve, and 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: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:

　　Novartis: e-mail [email protected] or call +1 (877)395-2339

　　Sandoz: e-mail [email protected] or call: +1-609-422-4098

　　Role Requirements

　　• Degree in natural/biological sciences or equivalent (or an equivalent mix of education and experience) Advanced degree desirable.

　　• 7+ of practical experience in pharmaceutical industry (e.g., preclinical safety, GLP/GCLP, bio analytics, in-vitro studies or related area).

　　• Minimum of 5 years of practical experience in any quality management system (e.g., GxP)

　　• In-depth knowledge of Industry Quality Standards and International Regulations (OECD, FDA, EU) and animal welfare regulations

　　• Expertise in the conduct of internal and external quality inspections and audits

　　• Excellent knowledge of the different kinds of safety assessment studies

　　The pay range for this position at commencement of employment is expected to be between $158,400 and $237,600.00; however, while salary ranges are effective from 1/1/24 through 12/31/24, 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 sign-on 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 “at-will 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.

　　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. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

　　You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook: https://www.novartis.com/careers/benefits-rewards

　　Commitment to Diversity and Inclusion:

　　Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

　　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 e-mail to [email protected] call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

　　Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

　　Division

　　Biomedical Research

　　Business Unit

　　NIBR QUALITY & COMPLIANCE

　　Location

　　USA

　　Site

　　Cambridge, MA

　　Company / Legal Entity

　　Novartis Pharmaceuticals

　　Functional Area

　　Quality

　　Job Type

　　Full Time

　　Employment Type

　　Regular

　　Shift Work

　　No