US02 Lonza Biologics Inc.
QA Director - Quality Systems (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.
Responsible for the following functional areas: Quality Systems, Documentation & Records Management, Product Quality Review (PQR), Quality Risk Management (QRM), QA Raw Materials Management, and Inspection and Audit Management. The incumbent is responsible for implementing and maintaining a continuous improvement program for the associated Quality Systems and implementing strategy at the site.
The QA Director – Quality Systems ensures that the GMP systems and controls in place at the site meet Global Quality Standards and applicable regulatory requirements. S/he liaises with Global Quality leadership and is a conduit for driving harmonization and alignment within the biologics network. Additionally responsible for ensuring that significant quality concerns are documented within the Quality Management System (QMS) and for maintaining systems that prompt the appropriate mitigation/remediation actions. This position typically has several direct reports (QA Managers, QA Supervisors), supports the overflow of tasks, assigns resources and priorities, ensures adequate training, coaches and develops staff, and evaluates performance. The QA Director – Quality Systems is a member of the Senior Quality organization and participates in decisions and escalations at the site.
Responsibilities
Partners with the Site Quality Head and Global Quality leadership to ensure alignment and approach in executing the strategic quality goals.
Oversees the hiring process for Quality Systems personnel, provides performance feedback, coaches, mentors and supports career development.
Sets direction for Quality Systems teams that is current with industry trends, guidelines and regulations. Monitors progress and ensures continuous improvement initiatives are completed.
Conducts regularly scheduled 1 on 1 meetings with staff, and conducts regularly scheduled team meetings to review objectives, provide support and feedback, and assistance in resolving issues.
Designs and implements Quality System improvements while ensuring high level internal / external customer support.
Acts as a point of escalation for QA staff and customers.
Provides TrackWise Quality System site administration, i.e. maintain personnel records, site user accounts, provide user support/ helpdesk/ troubleshooting.
Attends Change Control, Deviations Review and CAPA Board meetings as needed.
Manages and tracks Key Performance Indicating Quality Metrics including compilation of monthly/quarterly deviation trending reports for site management.
Owner of Site Quality Council meeting.
Leads Product Quality Review (PQR) administration.
Supports Customer audits and/or Regulatory inspections.
Oversees Supply Chain Integrity (SCI) program and other activities that assures the supply/delivery of materials that are suitable for GMP use.
Performs other duties as assigned, including reviewing and approving various documents (e.g. Product Quality Reports, Quality Agreements, Deviation Reports).
Key Requirements:
Bachelor's Degree
Experience managing direct reports (including people managers) and demonstrated ability to mentor and coach employees
Biotechnology manufacturing background is preferred
Deep knowledge of GMPs and global regulations
Demonstrated quality decision making skills
Experience participating in Domestic and International Regulatory inspections preferred.
Experience in Corporate Quality System initiatives (Six Sigma, Lean, etc.) a plus.
Self-motivated person with excellent written and verbal communication skills to all levels, ability to tolerate challenging workloads and changing priorities.
Strong attention to detail is essential.
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.