Manager, Compliance

United States, Quakertown (Pennsylvania)

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.

Lonza is currently recruiting for a Manager of Compliance for our Quakertown, PA site to join the team.

Key responsibilities:

  • Leads internal and external audits, and tracks audit and inspection commitments
  • Oversees, manages the controlled substances program, quarterly reporting of controlled substance inventories, license renewals and registrations
  • Oversees, manages FDA reporting for pharmaceutical and human food license renewals and registrations
  • Oversees, manages, implements and evaluate the supplier management program in accordance with the local, federal and EU regulations
  • Selection, evaluation, monitoring, qualification, disqualification and re-evaluation of the supplier of materials and/or services
  • Oversight for compliance of change controls, CAPA (Corrective and Preventative Action), investigations, deviations and OOS (Out of Specification)
  • Performs document reviews of SOP’s (Standard Operating Procedures), batch records, test methods, and logbooks to ensure cGMP (Good Manufacturing Practices) activities are completed and documented in accordance with approved, written procedures 
  • Independently writes SOPs or associated documentation.
  • Independently approves SOPs, Master Batch Records, customer audit and regulatory CAPA
  • Assesses potential impact to product quality for open deviations during lot release
  • May participate in investigations into minor major root cause, corrective or preventive actions and impact to product safety, identity, strength, quality or purity; trend and track applicable data
  • Contact for regulatory audits and inspections; may also run the back room during audits and inspections
  • Leads internal and external audits, and tracks audit and inspection commitments
  • May be responsible for hosting or leading a team in the front room for customer audits and regulatory inspections
  • Makes recommendations of changes to processes and programs
  • Trains team members
  • Performs other tasks as needed and assigned to support the local Quality Site-Head and overall quality and compliance at the site

Key requirements:

  • A minimum of a Bachelor’s degree or equivalent work experience is required.
  • Quality Compliance experience within the pharmaceutical/food industry is required.
  • Demonstrated supplier management and audit experience
  • Excellent communication skills (written and oral) with ability to influence people and outcomes
  • Good leadership skills
  • Strong interpersonal skills
  • Analytical Mind
  • Ability to work in a deadline driven environment
  • Ability to define specific goals clearly, to develop and prioritize activities
  • Familiarity with TrackWise and Documentum a plus
  • Candidates must be self-starter.

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. 

Reference: R32838