Mgr Quality Control

jj; Leiden; On-site; EUR 69,000 - 120,000; Full time

Job summary

Janssen Biologics B.V in Leiden, NL, seeks a Manager AVA/Mycoplasma Quality Control to lead the AVA/Mycoplasma QC team within the Leiden QC labs. The role requires a strong background in release of marketed products, viral/microbial methods, and people management.

You will mentor Supervisors and specialists, drive data integrity and regulatory compliance, manage budgets, and collaborate with QA, manufacturing, and external partners to ensure timely testing and continuous improvement of QC

Qualifications

• Masters / PhD or equivalent in virology, microbiology, life sciences, biotechnology or equivalent.
• 5–10 years in viral and microbiological method development and validation.
• Experience leading a 5–10 direct reports team.
• Regulatory knowledge (FDA, EU) in general and viral/microbiological topics.
• Strong leadership, problem-solving and process excellence experience.
• Prior experience with Next Gen Sequencing and rapid microbiology methods preferred.

Responsibilities

• On time delivery of release and stability sample testing results for the AVA/myco team.
• Ensure tasks comply with safety policies, quality systems and cGMP requirements.
• Set goals and KPIs for department and monitor performance.
• Ensure data generation, trending and integrity per regulatory requirements.
• Lead Supervisors and specialists with operational and strategic guidance.
• Collaborate with QA, Stability Owners, Development, Manufacturing and other stakeholders.

Skills

Viral & microbiology expertise

Team leadership

Process Excellence

Regulatory knowledge (FDA/EU)

Quality data integrity

Strong presentation skills

Digitalization & analytics

Next Gen Sequencing knowledge

Education

Masters / PhD in virology, microbiology, life sciences, biotechnology

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

People Leader

All Job Posting Locations:

Leiden, South Holland, Netherlands

Job Description:

Janssen Biologics is currently recruiting a Manager AVA/Mycoplasma Quality Control within our Quality department. The successful candidate needs to have a background in release of products that are on the market, people and team management skills, viral and bacterial knowledge, and a profound knowledge of pharmaceutical GMP principles. You will be reporting to the QC Director Biotherapeutics.

About the Company:

Janssen Biologics B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson that has been for more than 25 years a leader in the field of biomedicines. We continue to seek innovative ways to treat cancer, infectious diseases, cardiovascular and metabolic diseases, and immune-mediated inflammatory disorders, such as rheumatoid arthritis and psoriasis. Janssen Biologics in Leiden is manufacturing key Biotherapeutic products, like Remicade, Stelara, and Simponi, and is also launching new products.

The QC laboratories department in Leiden is part of the supply chain (JSC) organization and is responsible for testing of raw materials, release and stability of Active Pharmaceutical Ingredients and Drug products manufactured at Leiden, other internal J&J sites and at external third parties. Leiden JSC QC is uniquely positioned as the worldwide HUB for Stability and for AVA and Mycoplasma testing. The AVA/Mycoplasma department consists of approximately 25 people.

You’ll be part of the QC Management team working on successes for today and the future. You will lead with credo principles at hand ensuring diversity and inclusion, shaping, simplifying, and innovating the testing methods in close collaboration with Analytical Development (AD) colleagues. Your team will be onboarding several New Product Introduction (NPI’s) and pioneering automated testing solutions.

The responsibilities & the impact YOU will have:

• On time deliveryof release and stability sample testing results of the AVA/myco team
• Ensuring tasks are performed in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Setting goals and objectives for the department and define Key Performance Indicators that are indicative for excellent performance.
• Ensuring that data is generated, trended, and maintained according to current regulatory requirements, including data integrity.
• Lead Supervisors and specialists and provide operational and strategic guidance.
• Contributes to global strategies related to QC laboratories which align with compliance and business objects as well as the overall J&J vision.
• Act as a Servant Leader to coach and develop team members, driving business performance by successful talent development.
• Manage departmental budget, project budgets and resources; prepares staffing plans. Align roles and responsibilities of department to meet business needs.
• Collaborate with Quality Assurance, Stability Owners, Development, Manufacturing, Technical Operations, Engineering and Maintenance and other local and global stakeholders to support business needs.
• Responsible for timely completion of laboratory investigation of OOS/ invalid assays, CAPAs and change controls
• Acting as change agent and build and maintain team capabilities to meet current and future needs.
• Achieving innovation and excellence in business processes.
• Sponsoring projects at site/department/quality level.
• Lead internal and Health Authority audits inspections and related investigations.

QUALIFICATIONS

We would love to hear from YOU, if you have the following essential requirements:

• Masters / PhD or equivalent degree required in virology, microbiology, life sciences, biotechnology or equivalent.
• 5 - 10 years of experience in:
  • Expertise in viral and microbiological method development and validation,
  • Leading a med (> 20) sized specialized group (5-10 direct reports),
  • Quality Control in pharmaceutical industry with marketed products.
• Profound knowledge of pharmaceutical regulations/cGMP principles (FDA, EU, etc.) in general, and viral and microbiological topics specifically
• Organizational planning and problem-solving experience.
• Strong leadership & development qualities.
• Experience with principles of Process Excellence
• Good presentation skill
• Personal and social skills: informed decision making, digitalization and digitization, analytical thinking, strong quality awareness and flexible.
• Prior experience with Next Gen Sequencing and rapid microbiology testing methods is preferred.

Required Skills:

Preferred Skills:

Benchmarking, Compliance Management, Developing Others, Human-Computer Relationships, Inclusive Leadership, Leadership, Operational Excellence, Performance Measurement, Product Testing, Quality Control (QC), Quality Control Testing, Quality Management Systems (QMS), Quality Standards, Quality Validation, Standard Operating Procedure (SOP), Tactical Planning, Team Management

The anticipated base pay range for this position is:

€68600,00 - €119600,00