Site Head of Quality, Lexington (Biotech)

 

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.

Reporting to the Global Head of Quality for Cell & Gene Technologies, the Site Head of Quality will be responsible for leading and strategically directing the Quality Assurance and the Quality Control organizations to meet corporate business objectives at the Lexington, MA exosome manufacturing Center of Excellence and clinical manufacturing site.   Accountable for being the leading source of Quality and Good Manufacturing Practices (GMP) related expertise, this position will support the initial integration and continuous improvement, execution and administration of a Quality System, meeting all phase-appropriate compliance and regulatory requirements with respect to early stage (GMP), and a ensuring a strong partnership with Manufacturing, Facilities & Engineering, and other site support functions.

The Site Head of Quality will be expected to ensure that teamwork, high morale and innovation are fundamental components of the team while ensuring compliance, that is commensurate with the overall plan of the site and company, as well as client needs, is met. 

Key Accountabilities:

• Evaluate all current Quality systems to ensure appropriate compliance and operational effectiveness to meet site, business and client objectives.
• Monitor quality programs, policies and procedures to ensure compliance with GMP standards, corporate policies, Food and Drug Administration (FDA), European Medicines Agency (EMA) and other applicable regulatory body regulations and guidelines.
• Recommend solutions to complex quality issues and work closely with senior management to resolve significant issues.
• Act as Key Account Quality Manager for selected customers.
• Manage audit and monitoring plan.
• Develop KPIs for quality in line with site and Lonza standards.
• Oversee all regulatory authority audits and inspections.  Act as subject matter expert during regulatory inspections and take responsibility for corrective action programs in response thereto.
• Establish and maintain a positive working relationship with customers, the FDA and other regulatory authorities. Represent Lexington on quality and cGMP compliance issues that are relevant to the CGT network.
• Serve as the point person with industry partners regarding product quality matters, customer satisfaction levels and regulatory authority interaction.
• Serve as the company Quality expert, providing solid, well-informed, actionable Quality support to Operations, R&T, and other functions as requested.

Key Requirements:

• Bachelor, Master's Degree or PhD.  Preferred area of study in Science, Pharmaceutical Science or related field.
• 10+ years working experience with direct experience in early stage Quality
•  5+ years experience in GMP manufacturing and Quality Management of products regulated by FDA, CBER or CDER or EMA.

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.