Head of external manufacturing operations biologics Vacatures

Over de vacature

Overview

In this role you will lead Teva's external manufacturing network to ensure reliable patient supply, product quality, and compliant, cost-effective operations. You'll steer a cross-functional virtual plant team and serve as the primary operations interface with partner sites. You'll drive governance, risk mitigation, and continuous improvement across manufacturing, quality, regulatory and supply chain. This is a strategic leadership position with impact on enterprise-critical products and long-term supplier value. You'll work in a high-performance, collaborative culture that values growth and innovation.

Arbeidsvoorwaarden / Benefits

• generous annual leave
• reward plans
• flexible working schedules
• tailored health support
• Twist career development platform
• internal growth opportunities

Verantwoordelijkheden

• Coordinate end-to-end operations with external partners to secure patient supply, tech transfer, validation, regulatory approvals, and lifecycle changes
• Establish governance, metrics and management reviews across internal and external stakeholders
• Communicate priorities and performance outcomes to align cross-functional teams
• Identify and mitigate supplier and business risks with proactive contingency plans
• Resolve manufacturing delivery issues and partner-related challenges
• Collaborate with MSAT for process capability, control strategy, ROB, and COGS improvement
• Ensure ongoing cGMP compliance, inspection readiness, and quality governance with QA/Regulatory
• Sponsor investigations and cross-site technical improvements; manage manufacturing readiness
• Promote safety, health and environmental policy adherence in operations
• Drive Lean, digital manufacturing and standardization across external partners
• Build executive-level relationships with suppliers to enhance reliability and value creation
• Coach and develop cross-functional team members; manage projects and major initiatives
• Support capacity, capital planning, and major external manufacturing projects for compliance and growth
• Lead due diligence input on capacity and supplier network decisions
• Contribute to supplier strategy and contract development to ensure supply continuity
• Collaborate in License and Supply Agreement development to embed external manufacturing oversight

Belangrijkste vereisten

• 15+ years in biologics manufacturing/related roles

• 10+ years leadership in biologics manufacturing and external CDMO management

• Bachelor in Engineering (Master/MBA preferred)

• Strong knowledge of cGMP, tech transfer, process validation, quality systems, product lifecycle

• Experience with regulatory filings, inspections, and launches

• Financial acumen including COGS, S&OP/IBP, capital investment

• Proven cross-functional leadership and stakeholder influence across global matrix organizations

• Strong change management and continuous improvement track record

• Willingness to travel 25%

• collaboration

• influence and relationship-building

• communication

• cGMP

• technology transfer

• process validation

Over de vacature

Overview

In this role you drive the strategic quality oversight of external contract testing laboratories and cell banking operations to ensure GLP/GMP compliance, patient safety, and regulatory readiness. You lead a global quality function, partnering with external labs to protect product integrity and enable reliable launches. You will shape risk-based oversight, resolve quality issues, and mentor a high-performing team in a complex, regulated environment. This is a chance to influence quality governance across the contract testing network and accelerate remediation as needed.

Arbeidsvoorwaarden / Benefits

• medical, dental, vision insurance
• retirement benefits (401(k
• paid holidays
• vacation and sick days
• flexible benefits package
• compensation with bonus/long-term incentives (where applicable)

Verantwoordelijkheden

• Lead strategy, organisation design, budget oversight and performance management for CTLs and cell bank quality oversight
• Establish a risk-based quality oversight model for CTLs and for cell banking
• Provide operational leadership for drug substance, drug product and finished product testing
• Oversee quality compliance of CTLs with regulatory expectations and GLP/GMP requirements
• Oversee quality issues, OOS investigations, and deviations impacting launch or supply continuity
• Lead analytical technology transfer quality oversight
• Define performance metrics and governance routines to monitor quality and operations
• Lead quality assessments for prospective CTLs or new method candidates and remediate gaps
• Establish and maintain quality agreements to protect company quality and compliance
• Direct, mentor, and develop a high-performing QA team dedicated to external testing oversight
• Foster a culture of accountability, collaboration, operational excellence, and proactive problem-solving across internal and external networks

Belangrijkste vereisten

• Minimum of ten (10) years in Quality Systems/QA/QC within pharmaceutical manufacturing under global GMP and health authority requirements

• Proven track record managing complex quality investigations, risk assessment, and data-driven decisions

• Strong compliance background with experience supporting regulatory inspections and health authority interactions

• Demonstrated success leading and developing teams

• Ability to travel 30% of the time, including short-notice travel

• leadership and people development

• collaboration and cross-functional influence

• problem-solving and decision-making

• quality governance models

• supplier oversight and risk-based quality management systems

• external partner leadership (biologics/vaccines)