Vice President - Manufacturing

Role Objective:

The key objective of this role is to provide global strategic and operational leadership for Biotech's manufacturing network of six sites, producing sterile implantable ophthalmic devices, sterile hyaluronic-acid-based products and ophthalmic surgical consumables.

The role is responsible for safe, compliant, right-first-time and cost-competitive manufacturing; delivering the production plan agreed through S&OP; driving sustained COGS and per-unit cost reduction; commissioning new capacity on time, on budget and on specification; and keeping all manufacturing sites inspection-ready at all times for US FDA, EU MDR Notified Bodies, HPRA, ANVISA, CDSCO and MDSAP.

The position is the senior-most manufacturing leader in the organisation, partnering with the CEO, the senior leadership team and cross-functional teams on network strategy, investment and long-term capability building.

Desired Candidate Profile:

Education:

Master's in Engineering or Pharmacy with MBA/PGDM preferred.

Experience & Role Requirements:

- 20+ years of manufacturing experience in medical devices/sterile pharmaceuticals, including 8 - 10 years in multi-site leadership and management of large-scale, international operations.

- Strong hands-on expertise in sterile/aseptic manufacturing, terminal sterilization, sterile filling, cleanrooms, environmental monitoring, sterile filtration, bioburden control, packaging validation, and sterility assurance.

- Proven experience in greenfield/brownfield plant commissioning, manufacturing transformation, automation, site transfers, capacity planning, and business continuity.

- Strong track record in regulatory inspections, remediation, global QMS/GMP compliance, and applicable medical device, ophthalmic, implantable, sterilization, and sterile packaging standards.

- Demonstrated manufacturing excellence through Lean, Six Sigma, TPM, Kaizen, cost reduction, digital manufacturing systems, shop-floor automation, traceability, inspection, and analytics.

- Experience in global MedTech/sterile manufacturing environments, preferably with exposure to precision manufacturing, IOLs/OVDs, sterile filling, BFS, and management of in-house and contract sterilization operations.

Role & Responsibilities:

- Own the global manufacturing strategy, network footprint and 3 - 5-year capacity roadmap for all sites.

- Lead, direct and hold accountable the Site Heads and central manufacturing functions - Engineering & Projects, Manufacturing Excellence, MSAT / Technology Transfer and EHS.

- Build a high-performing manufacturing leadership team, with succession plans for every Site Head and critical role.

- Keep every site permanently inspection-ready, working hand-in-hand with the independent Corporate Quality Assurance function; own site-level deviations, CAPA and root-cause analysis to closure.

- Maintain sterile / aseptic manufacturing to the highest standard - cleanroom classification and monitoring, water and HVAC systems, media fills and a contamination control strategy per EU GMP Annex 1.

- Ensure effective validation, control, and periodic revalidation of sterilization and sterile barrier packaging processes in line with applicable standards, including oversight of contract sterilization providers.

- Deliver the monthly S&OP production plan with 95% schedule attainment, ensuring OTIF delivery of finished goods in partnership with Supply Chain.

- Ensure site gross margin as per approved budget and drive a per-unit cost-reduction roadmap through conversion-cost discipline, daily production cost and yield reviews, BOM control, waste elimination, automation and capacity utilisation.

- Build a Lean / Operational Excellence culture through tiered Kaizen, TPM and Six Sigma projects with measured, audited savings, and lead the manufacturing digitalization roadmap.

- Deliver capex and expansion projects from conception to commissioning, qualification and regulatory approval - on time, on budget and on specification.

- Lead technology transfer and new product introduction from R&D to commercial manufacturing, including scale-up, process validation and design-transfer readiness.

- Own EHS and business continuity for all sites - zero lost-time injuries, environmental compliance and tested contingency plans for critical utilities, equipment, sterilization capacity and single-site products.

- Govern manufacturing Opex and Capex budgets, support strategic investment and make-vs-buy decisions, and establish and report manufacturing KPIs for management review.

Functional Skills Required:

- Strong experience in multi-site sterile manufacturing network management, including capacity planning, Capex evaluation, and make-vs-buy decisions; working knowledge of SAP manufacturing and costing modules, with S/4HANA exposure preferred.

- Quality-first leadership with strong strategic thinking and financial acumen.

- Proven ability to execute transformation, develop leaders across sites, and influence senior cross-functional stakeholders.

Team Size to be Handled:

- Direct reports: Site Heads and Central function heads.

Important Links:

- Website: https://biotechhealthcare.com/

- LinkedIn: https://www.linkedin.com/company/biotechhealthcare/

Biotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.