Catalent · 23 hours ago
Global VP of Quality - Biologics
Bridgewater, NJ
Full-time
Onsite
Director/Executive
$320K/yr - $350K/yr
10+ years expCatalent is a global leader in drug development and delivery, and they are seeking a Global Vice President of Quality for Biologics. This role is responsible for overseeing global strategy and operations for biologics, ensuring compliance with regulatory requirements, and promoting a culture of quality across multiple sites.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Establishing and maintaining governance over the Quality Management System to ensure the site is operating effectively and in a state of control and build a culture of quality
Provide strategic direction, quality plans and staffing requirements in line with SLT to drive business priorities
Ensuring that controls are implemented and completed satisfactorily during manufacturing operations
Ensuring that developed procedures and specifications are appropriate and followed
Approving and rejecting incoming materials, in-process materials and drug products
Reviewing production records and investigating any unexplained discrepancies
Ensuring Executive management is well informed, advised and where appropriate makes decisions that are under the responsibility of the Quality Unit. Provides guidance, actions and risk mitigation plans and advice on strategic initiatives and other relevant ongoing operational issues/performance
Partner effectively with other functional leaders (Product Development, Operations, etc.) and Site General Managers to develop and maintain a meaningful and robust Quality and Patient First and Quality culture across all aspects of the business
Champion, through clear and visible advocacy, Catalent's Quality Management System (QMS), and ensure strong technical and leadership capability at all levels of the Quality organization
Responsibility for ensuring the site Quality leadership teams is staffed with high caliber Quality leaders and professionals, driving strong and effective performance culture at all levels across the sites, and creating a strong succession pipeline for key leadership roles
Define activity-based cost models and work with sites to establish and execute a budget that is in-line with the requirements of the business to deliver on the testing, release and QMS commensurate with the needs of the business to operate effectively and efficiently
Ensure appropriate metrics and reporting/escalation processes are in place and being utilized to drive and improve required operational execution and performance levels and drive appropriate corrective actions planning when needed
Drive actions and remediation as required to meet the quality performance and standards sets for the site
Prepare regulatory observation responses and regulatory CAPA plans to meet expectations, ensuring accuracy and completeness
Drive execution and outcomes on critical deviations provide clear direction and oversight including the review and approval of the deviations as well as effective CAPA plans
Deliver on the annual goals and objectives established with and approved through the business unit
Demonstrate strong business and fiduciary responsibility in the management of their budgets, and broader business decision-making, acting as both functional and business leaders
Development of strong customer relationships, partnering with other Catalent leaders to establish outstanding performance and customer impact that acts as a true competitive differentiator
Evaluate existing processes and identifies improvement to enhance efficiency, consistency, and competitiveness within the market
Stay current on industry trends and integrate, as appropriate new technologies. Represent Catalent and industry consortiums
Qualification
Required
Bachelor's or Master's Degree in science, pharmacy or related discipline is required
Extensive experience (10+ yrs) in biologics ATMP (Advanced Therapeutic Medicinal Products) is a requirement
Experience in managing a multi-site quality function in Biologics, ATMP's or Vaccines is required
Indirect responsibility for the quality function of over 200 people
Demonstrated business acumen and ability to manage through difficult discussions with clients
Experience in managing a multi-site quality function in Biologics or Vaccines is required
Ability to operate effectively in an environment with high levels of ambiguity
Proven critical thinking aptitude in a demanding and fast paced environment
Possesses visionary leadership; ability to identify new trends in the quality and regulatory landscape, allowing Catalent to lead the industry
Proven experience in driving substantial improvements of quality performance across a broad range of initiatives including development and recruitment of talent, process improvements, elimination of exceptions/SOP standardization
Demonstrated experience of successfully leading a multi-site Quality leadership team, preferable in a matrix-style organization
Knowledge of global cGMP regulations including FDA, EMA, ANVISA, and other Tier 1 regulatory agencies
Demonstrated success in executing multiple major quality initiatives (such as: implementation of IT systems, upgrading plant regulatory status, commissioning new plant operation, etc.)
Must possess significant learning agility and must be able to get to the heart of issues succinctly and propose ideas with conviction
Continuous improvement mind-set and disposition is critical
Provides reliable / defendable interpretations of regulatory guidance for the customer and is capable of defending these positions to regulatory agencies
Ability to effectively present information and respond to questions from Executive Leadership team
Preferred
MBA or PhD as educational background is an advantage
Benefits
Competitive Medical, Dental, Vision and 401K
26 days PTO & 8 paid holidays
Company
Catalent
Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions.
10001+ employees
H1B Sponsorship
Catalent has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2021-01-06Acquired
Leadership Team
Alessandro Maselli
President & Chief Executive Officer
Charles Lickfold
Senior Vice President, Chief Information Officer
Recent News
2026-01-22
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