Senior Quality Control Manager

ZipRecruiter; Uxbridge (MA); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Senior Quality Control Manager to lead a dynamic team in the Method Validation department. This role involves developing the long-term vision for the team while ensuring compliance with regulatory standards and fostering a culture of continuous improvement. The ideal candidate will have a strong background in leadership, change management, and lean methodologies, driving efficiency and innovation across the organization. Join a company dedicated to making a meaningful difference in life sciences, where your contributions will positively impact millions of lives worldwide.

Qualifications

• BSc degree or equivalent experience in a relevant field is required.
• Experience in a CDMO or similar organization preferred.

Responsibilities

• Lead the Method Validation department and ensure compliance with GMP standards.
• Develop and implement lean lab principles to improve testing processes.
• Mentor and coach a team of over 40 staff members for continuous growth.

Skills

Leadership

Change Management

Lean Methodologies

Risk Management

Continuous Improvement

Education

BSc in a relevant scientific or technical field

Tools

6S

RCA

Kaizen

Job description

Job Description

Location: Slough. Visa and Relocation support are offered with this role. Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people.

In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The role:

The Senior Quality Control (QC) Manager reports directly to the Head of QC and is accountable for establishing and executing the vision and strategy for a developing method validation team located in Slough. This position entails overseeing the precise implementation of platform method evaluations, the validation of new methodologies, and the ongoing maintenance of platform methods, ensuring full compliance with applicable regulatory requirements.

Additionally, the role requires ensuring that the laboratory consistently meets GMP and Lonza Quality standards. The adoption of lean lab principles to streamline testing processes will be promoted, cultivating a culture of continuous improvement throughout the organization. Exceptional leadership and advanced people management skills are essential for this role, as the incumbent will lead a team of over 40 staff members while driving their professional and technical development.

Key responsibilities:

1. Develop and deliver the long-term vision of the Method Validation department while supporting the QC strategy and vision.
2. Ensure laboratory compliance and host customer/regulatory audits.
3. Provide leadership to improve the technical and scientific capabilities of the team, ensuring the delivery of high-quality study activities.
4. Identify and complete work packages that support drug development and commercial programs.
5. Devise and communicate the scientific roadmap for the department.
6. Implement efficient work processes, such as Lean Lab, 6S, and continuous improvement initiatives.
7. Coordinate financial aspects of the department, including revenue, profitability, and budget management.
8. Prioritize studies and resources to ensure timely delivery, with input from key collaborators.
9. Apply regulatory knowledge to ensure data compliance for IND/BLA submissions and adhere to guidelines.
10. Improve GMP systems for method validation and maintenance throughout their lifecycle.
11. Represent the department and QC services to customers, potential clients, external meetings, and other Lonza sites.
12. Provide coaching, mentoring, and training to develop the team’s skills and ensure continuous professional growth.

Key requirements:

• BSc degree in a relevant scientific or technical field, or equivalent experience.
• Experience in a CDMO or similar organization, with a preference for large molecules.
• Proven ability to mentor teams on lean methodologies and expertise in Continuous Improvement tools such as 6S and visual management.
• Strong skills in developing and performing change management strategies.
• Experience in annual performance review processes.
• Proficiency in risk management and implementing mitigation strategies.
• Expertise in facilitating improvement initiatives, such as RCA, Kaizen workshops, and Kata mentorship.
• Strong leadership experience, encouraging a culture of efficiency and innovation across departments.
• Project management skills, with a track record of successful project planning, execution, and monitoring.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility.

How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences.

In return, we offer the satisfaction that comes with improving lives all around the world—the satisfaction that comes with making a meaningful difference.