Director - Head of Quality Control, Biologics

Lonza Biologics Porriño SLU; Portsmouth (NH); On-site; USD 120,000 - 160,000; Full time

Job summary

Lonza Biologics is seeking a Director - Head of Quality Control in Portsmouth, NH. This role entails overseeing all aspects of Quality Control in the Mammalian Business Unit, leading a talented team to ensure operational excellence. Ideal candidates will have extensive experience in QC, strong leadership skills, and a commitment to regulatory compliance. Join Lonza to make a significant impact in life sciences.

Qualifications

• 10+ years of QC experience, preferably with a life sciences background.
• Proven leadership experience, with strong coaching and management skills.
• Excellent written and verbal communication abilities.

Responsibilities

• Lead the Quality Control Department overseeing various QC activities.
• Develop and execute the QC strategy, ensuring quality delivery.
• Drive continuous improvement initiatives meeting key performance indicators.

Skills

Leadership

Coaching

Management

Communication

Teamwork

Education

Bachelor's degree in Life Sciences

Job description

Director - Head of Quality Control, Biologics

United States, Portsmouth (New Hampshire)

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 you to be part of.

Job Summary:

The Head of Quality Control (QC) is responsible for Quality Control activities including biochemistry, microbiology, environmental monitoring, raw materials, stability, method transfer, instrument and software qualification, data integrity, sample management, and QC document management.

The Head of QC provides a safe, controlled work environment in all areas of responsibility while being aware of the site safety objectives and making sure these are communicated and understood by all staff. Provides guidance to supervisors and other frontline leads to achieve goals in accordance with established policies. Establishes and recommends changes to policies which affect subordinate organizations. Develops and administers budgets, schedules, and performance requirements.

The role will be responsible for championing operational excellence and innovation as well as QC financial targets, to ensure stable planning of QC activities as per site needs. Responsible for people development and growth. Creates a culture in the QC organization that leads to employee satisfaction and retention. Contributes to the site’s growth strategy, including planning, budgeting, and safety.

Key Responsibilities:

1. Partners with the Site Quality Head, Site Leadership Team, and Global Quality functions in executing the strategic goals of the company.
2. Lead the Quality Control Department for the Mammalian Business Unit at Lonza Portsmouth, overseeing groups such as Raw Material, Analytical, Biochemistry, Microbiology, Environmental Monitoring, Assay validation/transfer, laboratory information, and sample logistics, including all personnel.
3. Develops and executes the QC strategy for the site, ensuring quality and delivery meet or exceed stakeholder and customer expectations.
4. Oversees raw materials testing, in-process and finished product testing, environmental monitoring, microbiology, stability testing, method transfer and validation, instrument and software qualification, QC data integrity, sample management, and QC document management.
5. Drives continuous improvement initiatives to meet key performance indicators.
6. Evaluates and prioritizes QC projects, focusing resources on strategic objectives.
7. Collaborates with Program Management, Quality Assurance, Manufacturing, and customers to support product lifecycle projects.
8. Participates in Site Quality Council and other relevant meetings.
9. Conducts regular team meetings and one-on-one staff meetings to review objectives and resolve issues.
10. Builds expertise within the QC organization, supporting staff development.
11. Represents QC in joint steering committees and supports regulatory and customer audits.
12. Manages the QC budget process.
13. Supports shared services for the Cell & Gene Therapies Business Unit, including raw materials, QC systems, and sample logistics.
14. Approves starting materials, packaging materials, intermediates, bulk, and finished products.
15. Ensures compliance with cGMP and safety regulations.
16. Participates in multidisciplinary customer teams and global QC work teams.
17. Leads development and implementation of operational excellence systems.
18. Ensures escalation of non-compliance issues.
19. Plans resources for QC to support projects and testing aligned with production.
20. Leads method transfer activities for customer projects.
21. Leads audits/inspections by customers and regulators.
22. Develops and coaches QC staff to improve performance and competencies.
23. Supports timely release of test results and batch release documentation.
24. Ensures manufacturing and testing compliance with cGMP, SOPs, policies, and specifications.
25. Approves specifications, sampling instructions, and test methods.
26. Ensures qualification and maintenance of QC premises and equipment, including validations.
27. Applies Data Integrity principles in all work aspects, in line with Lonza DI policies.
28. Performs any other duties assigned by the Site Quality Head.

Key Requirements:

• Bachelor's degree in Life Sciences preferred; a combination of education and experience with 10+ years of QC experience will be considered.
• Proven leadership experience.
• Strong coaching, management, and leadership skills.
• Ability to present ideas effectively to inform, educate, and influence.
• Excellent written and verbal communication skills.
• Ability to relate well in a team, actively listen, and coach staff.
• Maintain a positive attitude and emotional composure.
• Ability to manage meetings and deliver difficult messages.
• Experience in mentoring and leading teams.

At Lonza, we are committed to ethical practices and equal opportunity employment. We value the positive impact our products and services have on millions of lives worldwide, and we strive to uphold these standards in all aspects of our work.