Global Head of Quality Operations

vor 1 Monat

Basel, Basel-Stadt, Schweiz Lonza Vollzeit
Job Summary

We are seeking a highly experienced and skilled Global Head of Quality Operations to join our team at Lonza. As a key member of our leadership team, you will be responsible for providing technical quality and regulatory expertise to our Biologics site network.

Your primary focus will be on supporting the development and execution of our Biologics Quality strategy, ensuring alignment with customer needs and linkage with our overall Quality and business unit strategies.

You will be responsible for implementing and monitoring quality programs, policies, and procedures to ensure compliance with GxP standards, corporate policies, and regulatory body guidelines.

As the point person with industry partners, you will serve as the primary contact for product quality matters, customer satisfaction levels, and regulatory authority interaction.

You will also support our site network with all partner and regulatory authority audits and inspections, overseeing corrective action programs in response thereto.

Key Responsibilities
  1. Provides leadership for Quality and Regulatory activities across the Biologics network
  2. Plans, directs, and controls all quality requirements and leads a team of DPS Quality Site Heads
  3. Hires and develops top talent to create high-performing teams and succession pipelines
  4. Ensures active training and development plans for Quality staff with the objective of driving the overall competence and maturity of the Quality organization
  5. First point of contact for the respective Biologics sites for any Quality and Regulatory related topics
  6. Identifies and resolves problems by implementing project-based solutions, delivers improved business performance against critical quality factors. Detects potential gaps and initiates corrective and preventive actions (continuous improvement)
  7. Oversees the training of overall quality specifications and standards. Works towards a quality-oriented culture across the organization
  8. Ensures site alignment with all recognized local and international standards
  9. Ensures decisions are fully supported by Lonza Global Quality as well as local Quality and Regulatory organizations
  10. Provides expertise/coaching, assisting the Biologics sites and their teams for harmonized implementation of Quality policies, procedures, and specifications
  11. Contributes to the development and maintenance of global and local quality systems in line with current regulatory requirements
  12. Supports the transition from traditional QA compliance practices towards new frameworks for the regulatory oversight of manufacturing quality (cGMP in the 21st century)
  13. Closely follows industry trends and engages in industry associations to develop innovative future manufacturing concepts (e.g., BPOG, etc.)
  14. Active member of the Lonza Biologics Quality Leadership Team (BQLT) and the DPS BULT
Requirements
  1. Master's Degree or equivalent experience - Quality Management, or related science discipline
  2. Relevant experience in a regulated pharmaceutical industry including, manufacturing, quality assurance, quality control, R&D, and/or drug regulatory affairs
  3. Experience of chemical and biological GMP API manufacturing with demonstrated ability to interpret and implement related quality and regulatory requirements in a cGMP environment
  4. Proven management experience in an EMA/FDA regulated environment, and have an excellent working knowledge of current ICH, PIC/S, EU, and US regulatory requirements and their implementation
  5. Leadership role in Operations readiness including the onboarding and training of new staff – both quality and operations
  6. Experience in managing Swissmedic, USFDA, EMA, MHRA audits, etc.
  7. Experience hosting and managing inspections and audits
  8. Excellent knowledge of computer systems (i.e., Microsoft Word, Excel, PowerPoint, and Visio) with demonstrated skills in the use of information management systems in a GxP environment (TrackWise, DMS, LIMS, SAP, etc.)
  9. Working knowledge of modern approaches to compliance such as cGMP in the 21st century
  10. Working knowledge of modern quality tools such as risk-based approaches – FMEA, statistical process control, design of experiments, and Six Sigma
  11. Profound working knowledge of cGxP regulations and regulatory trends as they pertain to the stated responsibilities
  12. Strong verbal and written communication skills (English and German)
  13. Ability to communicate quality and compliance requirements to varying levels and functions of the organization
  14. Proven ability to lead, mentor, and coach direct reports and teams with or without direct line responsibility
  15. Strong organizational skills, ability to balance multiple priorities simultaneously
  16. Ability to solve problems, detail-oriented, understands the strategic picture, provides practical solutions. Strong analytical and investigative skills
  17. Understands the risk-based approach recommended by Lonza's planning for quality system

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