Quality Head, 20K
Company: Lonza Group AG
Posted on: June 12, 2021
United States, Portsmouth (New Hampshire)
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 incumbent leads all aspects of QA operations for a
Commercial GMP mammalian manufacturing asset and ensures that
manufacturing related GMP systems and controls meet Global Quality
standards and applicable regulatory requirements. In addition, this
role will liaise with the customer on a regular basis and
participate directly in Joint Quality Steering Committees to ensure
that QA and compliance activities meet their expectations. The
incumbent typically has several QA Managers/Supervisors as direct
reports and is responsible for overseeing change control, deviation
investigation and CAPA lifecycle, GMP compliance, on the floor
operational support, batch record review and lot release, review
and approval of technical documentation as well as oversight of all
validation activities in support of manufacturing operations within
the asset. This role is a member of the Senior Quality organization
and participates in decisions and escalations at the site.
- Develop and lead the overall quality strategy within the asset.
Partner with Site Quality Head, Asset Heads and Sr. QA Managers to
ensure alignment of Manufacturing and support functions and
approach in executing the strategic goals of the site.
- Collaborate with key customers on quality strategy and Quality
- Serve on joint Lonza-customer teams. Act as the lead SME for
significant quality/GMP issues including review and oversight of
complex deviations, CAPA and change controls.
- Provide overall direction for the QA functions within the
asset. Develop team goals, monitor progress and ensure continuous
- Conduct regularly scheduled 1 on 1s with individuals and staff
meetings with the teams to review objectives, provide support and
feedback and to help resolve issues.
- Contribute to the establishment of quality processes that align
with Lonza Corporate requirements and standards and current
regulatory requirements, meeting US FDA and European requirements,
and others as needed.
- Bachelor or Master's Degree. Preferred area of study in
Microbiology, Biochemistry, Chemistry or Related Science
- Extensive experience within a regulated cGMP industry.
- Substantial experience with team management.
- Extensive experience working in a QA role.
- Project management experience to drive projects to on-time
- Strong communication and interpersonal skills to grow and
mentor an effective team.
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
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
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
Keywords: Lonza Group AG, New England , Quality Head, 20K, Other , Portsmouth, Northeast
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