Global Head of Quality Operations, Biologics
We are looking for a Global Head of Quality Operations, Biologics responsible for providing technical Quality/Regulatory-related expertise and Quality Operational Management oversight to the Biologics site network.
About the Role:
* Provides leadership for Quality and Regulatory activities across the Biologics network
* Plans, directs and controls all quality requirements and leads a team of DPS Quality Site Heads
* Hires and develops top talent to create high performing teams and succession pipelines
* Ensures active training and development plans for Quality staff with the objective of driving the overall competence and maturity of the Quality organization
* First point of contact for the respective Biologics sites for any Quality and Regulatory related topics
* 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)
* Oversees the trainings of overall quality specifications and standards. Works towards a quality oriented culture across the organization
* Ensures site alignment with all recognized local and international standards
* Ensures decisions are fully supported by Lonza Global Quality as well as local Quality and Regulatory organizations
* Provides expertise/coaching, assisting the Biologics sites and their teams for harmonized implementation of Quality policies, procedures and specifications
* Contributes to the development and maintenance of global and local quality systems in line with current regulatory requirements
* Supports the transition from traditional QA compliance practices towards new frameworks for the regulatory oversight of manufacturing quality (cGMP in the 21st century)
* Closely follows industry trends and engages in industry associations to develop innovative future manufacturing concepts (e.g., BPOG, etc.)
* Active member of the Lonza Biologics Quality Leadership Team (BQLT) and the DPS BULT
Requirements:
* Master's Degree or equivalent experience - Quality Management, or related science discipline
* Relevant experience in a regulated pharmaceutical industry including, manufacturing, quality assurance, quality control, R&D and/or drug regulatory affairs
* Experience of chemical and biological GMP API manufacturing with demonstrated ability to interpret and implement related quality and regulatory requirements in a cGMP environment
* 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
* Leadership role in Operations readiness including the onboarding and training of new staff – both quality and operations
* Experience in managing Swissmedic, USFDA, EMA, MHRA Audits etc.
* Experience hosting and managing inspections and audits
* 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.).
* Working knowledge of modern approaches to compliance such as cGMP in the 21st century
* Working knowledge of modern quality tools such as risk based approaches – FMEA, statistical process control, design of experiments and Six Sigma
* Profound working knowledge of cGxP regulations and regulatory trends as they pertain to the stated responsibilities
* Strong verbal and written communication skills (English and German)
* Ability to communicate quality and compliance requirements to varying levels and functions of the organization
* Proven ability to lead, mentor and coach direct reports and teams with or without direct line responsibility
* Strong organizational skills, ability to balance multiple priorities simultaneously
* Ability to solve problems, detail/oriented, understands the strategic picture, provides practical solutions. Strong analytical and investigative skills
* Understands the risk/based approach recommended by Lonza's planning for quality system