Biotech - Vice President - Global Quality Lead

Global Quality Lead (Vice President)

Description:

Company Biotech Healthcare Group

Coverage

Lead Corporate and Site Quality (India (3) and Ireland (1) manufacturing units)

Business scope Ophthalmology, Orthopedics and Aesthetics (Dermatology)

Role Objective:

The key objective of this role is to define, lead and continuously strengthen the companys global quality strategy, governance and culture across all manufacturing sites and business units. The role is responsible for building a harmonized, inspection-ready and future-fit quality organization that ensures sustainable regulatory compliance, operational excellence, product quality, patient safety and customer trust. It will drive enterprise-wide quality management systems, digital quality transformation, risk-based decision-making and capability building while supporting business growth, new projects and international expansion.

Role Scope:

- Provide end-to-end quality leadership across 4 manufacturing sites, with current operations in India and Ireland and future project expansion.

- Build global quality capabilities spanning QA, QC governance, validation, qualification, compliance, digital quality systems, supplier quality, complaints, vigilance / PMS where applicable, and inspection management.

- Lead a quality organization of approximately 80-85 employees, including 8-10 direct reports at AGM to GM or equivalent senior leadership levels across geographies.

- Own and harmonize quality management systems for both medical device and pharmaceutical / sterile injectable environments, including PFS and BFS technologies where applicable.

- Act as executive quality interface for regulators, notified bodies, customers, partners and corporate leadership.

Desired Candidate Profile:

- Bachelors degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, Engineering or related discipline; advanced degree preferred.

- Typically, 18-22+ years of progressive quality experience, with significant senior leadership responsibility in regulated pharma, sterile injectables, medical devices, or a combination of these domains.

- Demonstrated ownership of global or multi-site quality organizations, including direct leadership of senior site / functional leaders.

- Strong exposure to both strategic quality transformation and operational quality governance.

- Track record of successful regulatory inspections and effective engagement with agencies and notified / certification bodies.

Key Accountabilities:

Global Quality Strategy and Governance:

- Define and deploy the global quality vision, policy and 3-year roadmap aligned to business growth, compliance, tech transfer and operational excellence priorities.

- Establish a harmonized governance model across corporate and site quality, with clear decision rights, escalation protocols, quality councils, and KPI routines.

- Ensure a strong independent quality voice in executive decision-making, product launch readiness, portfolio changes, and network expansion.

QMS and Compliance:

- Own the global QMS architecture covering document management, deviations, investigations, CAPA, change control, training, risk management, complaints, supplier quality, validation oversight, APQR / PQR, management review, data integrity and audit management.

- Drive sustained compliance with cGMP, EU GMP, US FDA expectations, ISO 13485 / relevant medical device requirements, CE-related quality obligations, HPRA, ANVISA and other applicable market regulations.

- Maintain a constant state of inspection readiness across all sites and quality systems.

Sterile / Injectable and Medical Device Quality Oversight:

- Provide strategic quality oversight for sterile manufacturing, aseptic processing, PFS / BFS operations, environmental monitoring, contamination control strategy, media fill / process simulation governance and process validation lifecycle.

- Ensure appropriate controls for medical devices and combination-like interfaces, including design / development quality where relevant, process controls, complaint trending, vigilance / PMS and field action governance.

Digital Quality Transformation:

- Lead selection, deployment, governance and optimization of digital quality platforms such as TrackWise, eBMR / MES interfaces, LIMS, DMS, LMS, QMS analytics and data dashboards.

- Use digital tools to strengthen cycle-time reduction, investigation quality, right-first-time, trending, management visibility and audit trail / data integrity controls.

- Partner with IT, manufacturing, engineering, and supply chain on validated system governance and digital roadmap execution.

Leadership, Capability and Culture:

- Lead, coach and calibrate a high-performing global quality leadership team across India and Ireland, ensuring clear succession plans and capability pipelines.

- Create a culture of quality, accountability and scientific rigor, while raising leadership maturity in investigation quality, risk-based decision-making and cross-functional collaboration.

- Set clear expectations and routines for site quality heads and corporate quality functions.

Projects, Expansion and Tech Transfer:

- Embed quality by design and compliance-by-design into greenfield and brownfield expansions, new lines, transfers and remediation programs.

- Approve quality requirements for qualification, validation, commissioning, change management and pre-approval / pre-license readiness.

- Serve as executive sponsor for enterprise remediation, quality maturity upgrades and major transformation programs.

External Interface:

- Lead regulatory inspections, notified body assessments, customer audits and high-risk partner escalations.

- Build strong supplier and contract partner quality governance, including qualification, oversight, performance review and risk escalation.

- Represent Biotech credibly with regulators, customers and senior stakeholders globally.

Critical Experience Requirements:

- Enterprise QMS design and deployment in complex regulated environments.

- Global / multi-country quality leadership across manufacturing sites.

- Deep experience in sterile / aseptic operations and injectable quality systems; exposure to PFS and/or BFS strongly preferred.

- Experience in medical device quality systems and post-market / complaint governance; ophthalmology experience is highly desirable.

- Hands-on experience with quality digital systems such as TrackWise, eBMR, LIMS, DMS / EDMS, LMS and quality analytics.

- Regulatory interaction with US FDA, EU / HPRA and other global health authorities; familiarity with CE-related quality expectations and ANVISA is highly valuable.

- Leadership of validation / qualification governance, data integrity, investigations, CAPA, supplier quality, and audit readiness.

- Experience supporting scale-up, remediation, site start-up, greenfield / brownfield projects, or network integration.

Leadership and Behavioral Expectations:

- Executive presence with the ability to influence site heads and international stakeholders.

- Decisive, risk-based judgment and calm leadership in high-pressure quality or compliance situations.

- High standards for integrity, independence, scientific thinking and data-based decision-making.

- Ability to simplify complexity, build followership and create alignment across operations, technical services, supply chain, RA, R&D and commercial teams.

- Change leadership capability to drive sustainable transformation rather than short-term remediation only.

Reporting Line and Organization:

- This role is an enterprise leadership role with authority across corporate and site quality structures. The incumbent should able to lead a team of approximately 80-85, including 8-10 direct reports from AGM to GM or equivalent senior-management levels, with cross-border oversight spanning India and Ireland.

- Reports to: CMD (Prompter of the Organisation)

- Team Structure: Manage a team size of approximately 80-85, including 8-10 direct reports.

Important Links:

- Website: https://biotechhealthcare.com/

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

- Instagram: Biotech Vision Care

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