Global Service Area Lead - CMC Development & Quality

ProductLife Group is a global consulting and outsourcing partner to the life sciences industry. We support pharmaceutical and biotechnology companies across the full product lifecycle, from early development through post-marketing activities.

We are seeking a Service Area Lead for CMC Development & Quality. This role defines and executes the global vision, value proposition, capability roadmap, pricing strategy, and operating model for an integrated CMC & Quality service offering.

• Enterprise strategic leader accountable for the global Quality & CMC Development service area, including strategy, financial performance (P&L), operational delivery, and capability scaling across regions.
• The Service Area Lead ensures high-quality, compliant, and scalable service delivery aligned with enterprise and Business Unit strategy.

• Owning financial performance (revenue, margin, utilization) and resource strategy.
• Ensuring consistent, high-quality, and compliant delivery standards globally
• Leading global teams, including Service Line Leads, and driving talent and succession strategies
• Driving innovation and technology enablement (including digital tools, QMS, and AI-enabled solutions)
• Leading business development strategy, proposals, and executive-level client engagement
• Establishing Communities of Practice and ensuring cross-regional alignment and governance
• Supporting M&A activities including due diligence, capability assessment, and integration

• Advanced degree (Master’s, PharmD or PhD) in Life Sciences, Pharmacy, Chemistry, Chemical Engineering, Biotechnology, or related field preferred.
• 15+ years of experience in CMC Development, Quality Assurance, Quality Systems, or related domains within biotech/pharma, consulting, or CRO environments, including significant global leadership experience.
• Demonstrated experience managing large-scale service lines, including financial performance, global delivery, and cross-functional team leadership.

• P&L and business leadership: Experience owning or contributing to P&L management, including revenue growth, margin optimization, utilization tracking, pricing strategy, proposal input, and executive‑level client engagement.
• Global delivery & operating models: Proven ability to design, govern, and scale compliant, high‑quality global service delivery frameworks, operating models, Communities of Practice, and cross‑regional coordination.
• CMC, Quality & Regulatory expertise: Deep end‑to‑end expertise across CMC development, QA, Quality Systems, global regulatory expectations (FDA/EMA/ICH), quality controls, CAPAs, risk/benefit analyses, and full product lifecycle oversight.
• Strategy, process & performance excellence: Ability to define and steer global CMC/QA strategy, capability roadmaps, service innovation priorities, harmonized processes, SOPs, KPIs, quality metrics, and continuous improvement systems using data‑driven insights.
• Innovation & technology enablement: Strong track record in driving innovation through digital platforms, technology enablement, and AI‑supported solutions.
• Leadership & talent development: Proven capability to lead and mentor global teams, manage resource strategies, coach leaders, oversee performance management, and build future organizational and consulting capability.
• Enterprise & external leadership: Ability to structure ambiguous problems, make enterprise‑level decisions, lead M&A assessments and integrations, align Regulatory, Clinical, CMC Ops and Quality functions, and represent the organization at industry and scientific forums.