Senior Director of Quality, CGT
Today, Lonza is a global leader in life sciences operating across three 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 Senior Director of Quality, Cell & Gene Technology will lead the quality organization (QA, QC) at the Houston site. This person will assure the site remains in compliance with respect to GMP and collaborating with Operations to solve quality issues. Will act as Key Account Quality Manager for selected customers while accomplishing corporate business objectives by developing site quality systems and enforcing Regulatory compliance. Will lead and support audits and regulatory inspections at the site. Will lead and direct both QA and QC staff members. Will develop compliance related manufacturing and process controls and improves quality systems. This person will also be a member of the Site Leadership team.
- The Quality Head for the site, is the leading source of Quality and GMP related expertise within the site and is responsible for providing the strategic leadership and management for the Site`s Quality organization
- Provide leadership to the Site Quality organization to ensure that teamwork, high morale and innovation are fundamental components of a team
- Develop and execute the Quality strategy commensurate with the overall plan for the company. Ensure alignment with customer needs and linkage with the overall Quality and business strategies.
- Implement continuous improvement initiatives to drive Quality programs and ensure maximum productivity. Ensure systems meet the needs of all internal and external constituencies with an emphasis on process, quality, productivity, budget control, and profitability.
- Develop, implement and monitor Quality programs, policies and procedures to ensure compliance with GMP standards, corporate policies, FDA, EMA and other regulatory body regulations and guidelines.
- Serve as the point person with industry partners regarding product quality matters, customer satisfaction levels and regulatory authority interaction. Oversee all partner and regulatory authority audits and inspections and corrective action programs in response thereto
- Evaluate all current Quality systems and processes and recommend and implement appropriate enhancements to ensure the achievement of Lonza’s long-term objectives
- Create active training and development plans for Quality staff with the objective of driving the overall competence and professionalism of the Quality functions.
- Establish and maintain a positive working relationship with customers, the FDA and other regulatory authorities. Represent the Lonza on quality and cGMP compliance issues that are specific to the site
- Serve as the company Quality expert, providing solid, well-informed, actionable Quality support to Operations, R&T, and other functions as requested.
- Bachelor’s Degree in a Life Sciences, Engineering or Quality Management or related science discipline required
- Highly experienced knowledge in GMP manufacturing and Quality Management of products regulated by FDA CBER or CDER or EMA.
- Proven experience in senior leadership positions in aseptic processing is a pre-requisite.
- Acts as a change leader by visibly demonstrating commitment to change, and aligning and helping others embrace change
- Challenges others to work differently when the business environment requires it
- Manages ambiguity through effective communication, removes barriers and overcomes resistance skillfully
- Translates corporate strategy into critical success factors and creates effective implementation plans
- Acts as a key communication link between operational layers and upper management
- Develops inclusive relationships and alliances engaging internal and external stakeholders
- Creates mechanisms to share information and knowledge across functions
- Builds and effectively manages diverse teams to enhance Lonza’s global competitiveness and innovation
- Finds the right balance between customer needs and business goals
- Manages interactions proactively to drive customer satisfaction
- Communicates regularly with peers/team members about customer topics to drive awareness and build capability
- Assure pragmatic problem solving is carried out with a strong sense of purpose and urgency and notify/make recommendations to Management regarding serious compliance or quality issues. Routinely report on quality and compliance issues
- Leads multiple complex initiatives simultaneously to successful conclusion
- Demonstrated leader in the field with sustained performance and accomplishments. Ability and experience in turning around and remediating compliance challenges.
- Ability to plan and budget at a senior level.
- Demonstrates high integrity and accountability for his/her area ensuring team(s) actions and decisions are aligned to business objectives
- Provides opportunities for talent and performance development through specific and measurable actions, coaching and mentoring
- Seeks feedback to understand impact on others; knows his/her own strengths and limitations, learns from mistakes
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.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.