Quality Assurance Operations Manager

About the Role

Quality Assurance(QA) Manager

Location: Millburn, NJ #LI-Onsite

Shift: Mon- Fri 2nd shift OR Wed- Sat 2nd shift

About this role:

Reporting to the QA Operations Head, the QA Manager is accountable for supporting the Production, Quality Control, Engineering, and Supply Chain operations at Radioligand Therapies Millburn Site. The QA oversight will cover routine product release, compliance activity support, and duties related to shop floor oversight.

This role may also support QC operations and process validation as required, but the primary responsibility will oversee Production, Engineering and Supply Chain Operations. The QA Manager role is responsible for supervision of QA personnel.

Key Responsibilities:

• Provide QA oversight of production, engineering, and supply chain operations through review/approval of test records for batch release, SOPs, C of As (as applicable), CAPAs, Deviations, change controls, and shop floor oversight. Provides the production, engineering MS&T, and supply chain teams with QA/Compliance guidance and decisions.

• Review and approval of deviations / non-conformances and lead the strategic discussion for investigations with respect to operations or validation/qualification related matters.

• Review and approve actions related to facility, computerized systems, laboratory or products. Ensure proper assessment with respect to Qualification and Validation is conducted. Performs QA oversight for Validation and Qualifications activities for Manufacturing, QC remediation work.

• Review and approve Standard Operating Procedures (SOPs), Quality Risk Assessments (QRAs), Quality Plans related to manufacturing operations, as needed. Contribute to generation of Annual Product Reviews for production, engineering and supply chain.

• Develop, maintain, and propose continuous improvement of quality systems and policies for production, engineering, and supply chain according to Advanced Accelerator Applications Global Quality Standards, applicable local and global regulatory requirements, and registered Product information.

• Support training program for QA operations associates which include shop floor programs and training curricula, batch record review and release, and the validation program training curriculum as well as operational quality systems and compliance.

• Drive continuous quality improvement program for manufacturing operations and partner with the production, engineering, and supply chain teams to implement/optimizes to improve efficiency (right the first time) and monitor/escalate as needed.

• Serve as SME for QA operations to support all regulatory inspections. Provide leadership during any periodic internal production, engineering, and supply chain self-inspections. Provide leadership and guidance during the preparation and participation of health authorities' inspections Support and regulatory filings.

• Actively drive high quality deliverables at the site by promoting a high standard of Quality Culture. Helps build and drive a culture of compliance throughout the organization.

• Inspire change management initiatives and embed collaboration forums across the sites and as required with stakeholders. Control project scope to limit schedule changes and to capture changes of scope that may arise.

• Perform or support any other tasks necessary to maintain the product quality and site cGMP compliance, as needed.

• Act as a Deputy to Quality Assurance Operations Head.

Diversity & Inclusion / EEO

The Novartis Group of Companies 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.

Role Requirements

Essential Requirements

• Bachelor's degree in Life Sciences. Master's degree a plus.

• 5 years of experience in GMP Pharmaceutical Manufacturing, with at least 3 years combined of relevant experience in Aseptic GMP Manufacturing Operations and/or Quality Assurance covering GMP manufacturing operations.

• Experience in leadership in roles as listed above.

• Proven track record and practical experience in supporting a GMP Manufacturing Operations unit and operating in full compliance with global cGMP requirements. Successfully managed inspections by major Health Authorities (e.g. US FDA, EMA).

• In-depth knowledge of cGMP, FDA regulations (21 CFR Parts 211, 212), and ICH regulations. In depth knowledge of QC regulations.

• Proven ability to manage multiple projects with moderate resource requirements, risk and/or complexity.

The pay range for this position at commencement of employment is expected to be between $107,200 and $160,800 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. 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

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

Why Novartis: Helping people with disease and their families takes more than innovative science.

It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?