Senior Director, Quality Site Head, Walkersville
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, Quality Site Head for the Walkersville, MD Site, is the leading source of Quality/Regulatory-related expertise and is responsible for providing the strategic leadership and management to approximately 40-60 people in the quality assurance and quality control functions. A great candidate will have strong leadership capabilities, envisioning and driving teamwork, high morale, quality culture, and innovation with the goal of building a world-class team. We are looking for someone comfortable working in a matrixed organization, effective with cross-functional and global projects, someone who can conceptualize where we need to be, how to get there, and drive ideas to completion.
The Senior Director, Quality Site Head is a highly visible member of the senior site leadership team and will spend the majority of the time onsite to support the key responsibilities listed below.
- Develop and execute the Walkersville 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 are world-class and 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 GxP standards, ISO standards, corporate policies, FDA and other regulatory body regulations and guidelines.
- Setting and driving compliance to department, site and global KPIs.
- Serve as the point person with industry partners regarding product quality matters, customer satisfaction levels and regulatory authority interaction..
- Evaluate all current Quality systems and processes and recommend and implement appropriate enhancements and trainings to ensure the achievement of Lonza’s long-term objectives.
- Establish and maintain a positive working relationship with customers, the FDA and other regulatory authorities. Represent Lonza on quality and cGxP compliance issues that are specific to Walkersville.
- Bachelor`s degree in a Life Science discipline, Engineering or Quality Management or related field; Master’s degree preferred
- Extensive experience with quality assurance, quality control, and regulatory compliance in a leadership capacity
- Substantial direct job-related experience in GMP facility manufacturing products regulated by Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), or Center for Devices and Radiological Health (CDRH) with significant experience in Quality Management
- Experience with lean manufacturing practices
- Working knowledge of:
- Aseptic practices and clean room operations
- Statistical and auditing techniques
- Environmental control procedures/equipment
- Expert knowledge of GxP, ISO Standards, FDA regulatory requirements applicable to FDA regulated products
- Strong knowledge of current industry trends and has the ability to use the latest technologies
- 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
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.