Head of Quality Systems and Compliance

Key Responsibilities:

• Act as Deputy to the Site Quality Head on all aspects of site quality inclusive of signing/approving GMP and other documents on behalf of the Quality Head as needed.
• Lead a group of associates (5 to 15 persons) and manage resources allocation to ensure timelines and key milestones are met.
• Ensuring that the Quality Management Systems, including policies, standards, processes and governance, developed are “fit for purpose” to provide a robust framework from development through commercialization of safe and efficacious products, including, monitoring and adapting to emerging regulatory standards and industry trends.
• Define, implement, monitor, consolidate and analyze Site Quality KPIs (in conjunction / alignment with global RLT quality), and effectively report to Site Leadership.
• Prepare, facilitate and lead the Quality Review Board (Management Review) for the site, including, identifying new or potential risks, ensuring mitigation activities (e.g., CAPAs) are established and implemented, and escalating concerns to site leadership, where appropriate. 
• Manage complaints, recalls, returns, FARs and facilitate escalations.
• Develop and implement the strategies, processes and plans for the inspection readiness and response planning.
• Develop and strengthen the Quality Culture within the Quality Unit and at Site level ensuring GMP compliance and continuous quality management improvement by facilitating and promoting empowerment and accountability.
• Lead CAPA Review Board and ensure investigations are correctly executed and adequate CAPAs are defined, and proper follow up of CAPAs effectiveness. 
• Coordinate the generation and monitor the execution of the Site Quality Plans, Site Quality Risk Assessments and other relevant gap assessments.

Essential Requirements:

• BSc in Chemistry, Biology, Pharmacy, or related experience.  Advanced Degree in Quality / Regulatory, Business, Healthcare, Pharmacy, or Scientific discipline preferred. 
• Minimum of 10 years’ experience in Quality Systems, Quality / Regulatory Compliance, Operational GxP area(s) (Manufacturing / Development), Quality Control, Quality Assurance, Supplier Quality and / or Post Market Quality within the pharmaceutical, diagnostic and / or medical device industries.
• Prior experience leading people is required. 
• In-depth knowledge of cGMP, applicable FDA Regulations (e.g., 21 CFR 4, 7, 11, 211, 212, 314, 803, 806, 820), ICH Guidelines, EU Pharmaceutical Regulations and Directives, ISO Standards, etc.
• Understanding of United States Pharmacopeia (USP), European Pharmacopeia (EP), American Chemical Society (ACS).
• Prior experience successfully leading Health Authority Audits / Inspections, including, front room / back room, readiness, strategy and response to findings / observations.
• Experience developing high performing teams and talent management.

Desired Requirements:

• Experience in process improvement approaches (e.g., Lean, Six Sigma, 5s) and leading projects is preferred.
• Prior experience with aseptic manufacturing preferred
• Experience in advanced therapies (CGT, RLT, etc) is preferred.
• Prior experience in a global, matrix organization is preferred.

The pay range for this position at commencement of employment is expected to be between $158,400 and $237,600 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.

Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: Novartis Life Handbook

Commitment to Diversity and Inclusion:

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.