Quality Control Laboratory Manager
1 week ago
Quality Control Laboratory Manager
Onsite | Monday–Friday, 8:00 AM – 5:00 PM | Miami, FL
Compensation: $120,000-$150,000/year
We are seeking an experienced
Quality Control Laboratory Manager
to lead a team of scientists and technical staff in a cGMP-regulated pharmaceutical environment. The ideal candidate will bring strong leadership in both
QA and QC operations
, a solid scientific foundation in
chemistry or biology
, and hands-on experience managing analytical and stability programs within a solid dose manufacturing setting.
Key Responsibilities
- Supervise and mentor a team of 17 QC professionals, including chemists, data reviewers, and support staff.
- Oversee all QC laboratory operations to ensure compliance with company policies, cGMP, and regulatory standards.
- Develop, implement, and maintain laboratory goals, objectives, and analytical procedures.
- Lead method transfers, method validations, raw material/in-process/bulk/stability/finished product testing, and data review.
- Maintain the laboratory's equipment calibration program and ensure all systems are audit-ready.
- Conduct and review laboratory investigations, author CAPAs, and ensure timely resolution of deviations.
- Oversee the development and maintenance of Certificates of Analysis and stability protocols.
- Support continuous improvement initiatives to enhance quality, efficiency, and compliance across laboratory operations.
- Collaborate cross-functionally with QA, manufacturing, and technical teams to ensure product quality and regulatory alignment.
Qualifications
- Bachelor's degree (minimum) in a
Chemical or Biological discipline
. - 7+ years of QC laboratory experience
in a regulated pharmaceutical or life sciences environment. - Proven
leadership experience
managing QC/QA teams and laboratory operations. - Strong knowledge of
GMP compliance
, analytical methods, and stability programs. - Proficiency with
Empower
and
LIMS
software systems preferred. - Solid understanding of
method transfer and validation
processes. - Experience in
solid dose pharmaceutical manufacturing
(background with companies such as Teva or Watson Labs is a plus). - Excellent written, verbal, and interpersonal communication skills.
- Local candidates preferred.
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