Associate Director, Quality Operations
Company: Lonza
Location: Hayward
Posted on: May 10, 2022
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Job Description:
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 Associate Director, Quality Operations will oversee all aspects
of quality assurance for the Lonza Hayward manufacturing facility,
ensuring that the quality systems and controls meet Lonza global
standards and regulatory requirements. The individual who fills
this role must be a strong partner with the Manufacturing
Operations teams and other teams that support operations (QC, MSAT,
FAC, ENG, VAL and QS). The QA Operations Head must also be a strong
partner with clients to ensure that project and delivery timelines
and expectations for product quality and GMP compliance are met.
Prior experience in biologics manufacturing is desired, but not
essential. A strong foundation in application of GMPs in a drug
substance manufacturing environment is critical, as is an ability
to quickly assess facts and make the appropriate decision when
process/product quality may be impacted.
Key Responsibilities:
Develops and implements the overall quality strategy for the
facility.
Partners with the Site Director, Head of Quality and Senior
Leadership Team to ensure alignment with Manufacturing and support
functions in executing the strategy.
Acts as the lead SME for significant quality or compliance issues
within the facility.
Manages QA Ops budget and resources to maximize efficiency and
maintain quality/compliance at high levels.
Develops, directs, and maintains quality systems in support of
manufacturing in a manner consistent with global quality systems,
Lonza Corporate requirements and standards and current regulatory
requirements, (primarily US FDA and European requirements) and
others as needed. Quality systems include but are not limited to
audits and inspections, documentation and records management.
Interfaces with site QA functions to support or develop appropriate
interfaces with the site-based QA systems.
Develop working relationships with other site functions for support
of equipment, facility, utility, cleaning services and computer
validation/qualification.
Oversees all aspects of QA operations within the facility,
including but not limited to executed batch record review, on the
floor QA support, raw material release, deviation investigations,
change controls, Quality Agreements, customer quality support and
SOP and master batch record review.
Responsible for release of bulk drug substance batches.
Ensures QA support for internal and external project and team
meetings.
Interfaces with customers and internal groups for resolution of
quality issues.
Has decision-making authority for any Quality issues; informs Site
Quality Head of critical issues in a timely manner.
Builds and maintains expertise in the QA Ops teams, including
development of staff.
Applies biologics manufacturing experience to ensure that
operations meet customer and regulatory expectations and
requirements for manufacturing at all phases of product
development.
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.
R39307 Associate Director, Quality Operations
Keywords: Lonza, Hayward , Associate Director, Quality Operations, Executive , Hayward, California
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