Site Quality Head, Florida (AD level)
Novartis
3 months ago
On-site
Winter Park, FL
$138,600 - $257,400 USD yearly
Operations
Key Responsibilities
- Lead site quality strategy and governance to meet Novartis standards and current Good Manufacturing Practice.
- Build, coach, and develop the Quality team, strengthening capability, engagement, and safe working practices.
- Drive plant startup, expansions, and technology transfer, ensuring compliant planning, commissioning, qualification, and validation activities.
- Lead inspection readiness and represent the site during health authority, corporate, and internal audits.
- Oversee deviations, investigations, out-of-specification events, and corrective and preventive actions through effective closure.
- Partner with Manufacturing and cross-functional leaders to enable compliant, efficient operations and risk-based decision making.
- Define and monitor site quality performance indicators, driving continuous improvement and timely escalation of risks.
Essential Requirements
- Bachelor’s degree in life sciences or a related scientific discipline.
- Ten years of experience in a GMP pharmaceutical manufacturing environment (including laboratory operations and Aseptic experience) and at least three years in Quality Assurance and/or Quality Control roles.
- In-depth knowledge of cGMP and FDA regulations and ICH regulations; understanding of USP, European Pharmacopeia, and ACS standards.
- Proven success leading health authority inspections and delivering robust remediation and sustained compliance improvements.
- Demonstrated leadership in matrix organizations with strong communication, organizational, and stakeholder management skills.
- Experience applying continuous improvement methods such as Lean Six Sigma, Total Quality Management, and 5S workplace organization.
Desirable Requirements
- Prior experience with site start-up or rapid site expansion.
- Experience or training in Radioligand Therapies, radiopharmaceuticals and/or radiation safety.
Benefits
- Performance-based cash incentive; eligibility for annual equity awards (depending on role level).
- Comprehensive benefits package (US-based eligible employees): health, life and disability benefits, 401(k) with company contribution and match, time off (vacation, personal days, holidays, and other leaves).
Application instructions (accessibility)
- For reasonable accommodations during the application process, email [email protected] or call +1(877)395-2339 and include the job requisition number.
- Lead site quality strategy and governance to meet Novartis standards and current Good Manufacturing Practice.
- Build, coach, and develop the Quality team, strengthening capability, engagement, and safe working practices.
- Drive plant startup, expansions, and technology transfer, ensuring compliant planning, commissioning, qualification, and validation activities.
- Lead inspection readiness and represent the site during health authority, corporate, and internal audits.
- Oversee deviations, investigations, out-of-specification events, and corrective and preventive actions through effective closure.
- Partner with Manufacturing and cross-functional leaders to enable compliant, efficient operations and risk-based decision making.
- Define and monitor site quality performance indicators, driving continuous improvement and timely escalation of risks.
Essential Requirements
- Bachelor’s degree in life sciences or a related scientific discipline.
- Ten years of experience in a GMP pharmaceutical manufacturing environment (including laboratory operations and Aseptic experience) and at least three years in Quality Assurance and/or Quality Control roles.
- In-depth knowledge of cGMP and FDA regulations and ICH regulations; understanding of USP, European Pharmacopeia, and ACS standards.
- Proven success leading health authority inspections and delivering robust remediation and sustained compliance improvements.
- Demonstrated leadership in matrix organizations with strong communication, organizational, and stakeholder management skills.
- Experience applying continuous improvement methods such as Lean Six Sigma, Total Quality Management, and 5S workplace organization.
Desirable Requirements
- Prior experience with site start-up or rapid site expansion.
- Experience or training in Radioligand Therapies, radiopharmaceuticals and/or radiation safety.
Benefits
- Performance-based cash incentive; eligibility for annual equity awards (depending on role level).
- Comprehensive benefits package (US-based eligible employees): health, life and disability benefits, 401(k) with company contribution and match, time off (vacation, personal days, holidays, and other leaves).
Application instructions (accessibility)
- For reasonable accommodations during the application process, email [email protected] or call +1(877)395-2339 and include the job requisition number.