Top 3 Laboratory director Jobs in Winston Salem Nc

Senior Director, Quality Control
ProKidney —Winston-Salem, NC
- Remote
- Microsoft Word
- Microsoft Excel
- Bachelor's degree
12d
Director Analytical Research and Development
Cambrex —High Point, NC
- Full-time
- Bachelor of Science
- Bachelor's degree
- Doctor of Philosophy
Director Analytical Research and Development
Cambrex Corp. —High Point, NC
- Full-time
- Bachelor of Science
- Pass drug screening
- Bachelor's degree
- Health insurance
- Life insurance

Explore jobs in cities nearby

Check out jobs in cities near your current location, Columbus

Director - Histocompatibility Lab
The Ohio State University Wexner Medical Center —Columbus, OH
This individual directs technological staff and works closely with attending physicians and fellows in both solid organ and bone marrow transplantation in the…
Director, Laboratory - System Anatomic Pathology
OhioHealth —Columbus, OH
Ensures hospital complies with blood handling and use standards as defined by JCAHO and any other state/federal/local regulatory body.

I want to receive the latest job alert for laboratory director in winston salem nc

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

laboratory director jobs near winston salem nc

Director Of Quality jobs in Winston-Salem, NC

Director Of Analytics jobs in Berea, OH

Director Of Analytics jobs in Dallas, TX

Director Of Analytics jobs in Atlanta, GA

Director Of Analytics jobs in Bentonville, AR

Regional Director Of Operations jobs in Minnesota

Athletic Director jobs in Pennsylvania

Data Analytics jobs in St. Louis, MO

Director Of Analytics jobs in Baltimore, MD

Director Of Analytics jobs in Astoria, NY

Director Of Analytics jobs in Palo Alto, CA

Sports Analytics jobs in Atlanta, GA

Director Of Analytics jobs in Pittsburgh, PA

Quality Engineer jobs in San Jose, CA

Director Of Maintenance Isd jobs in Texas

Quality Assurance Biotech jobs in San Diego, CA

Director Of Quality jobs in Orlando, FL

Director Of Quality jobs in Colorado

Quality Assurance Biotech jobs in San Francisco Bay Area, CA

Director Of Quality jobs in New Hampshire

Senior Director, Quality Control

ProKidney
Winston-Salem, NC

Apply Now

Job Details

12 days ago

Qualifications

Microsoft Word
Microsoft Excel
Presentation software
Bachelor's degree
Senior leadership
Pharmaceutical manufacturing facility experience

Full Job Description

The Sr Director of Quality Control will be responsible for leadership of the various functional responsibilities of the Quality Control department, including QC - Operations, QC - Incoming Raw Materials, QC - Systems & Services, and QC – Microbiology Sterility Assurance. The role will lead continuous improvement activities of all quality control systems and drive a continued state of inspection readiness. The leader in this role must ensure that quality documentation and controls are effectively in place for phase III investigational new drugs (investigational medicinal products) to meet all quality requirements and regulatory standards and meet continuous clinical supply and delivery expectations leading to commercialization.

Essential Duties & Responsibilities:

Directs the development, validation, planning, implementation, and maintenance of QC product tests and analytical methods, processes, and operations.
Supports the design and execution of the environmental monitoring and sterility assurance programs for GMP manufacturing operations.
Supports development of QC tests and analytical methods that support production, including design support
Validates analytical test methods for raw materials and finished goods
Oversees raw material, in-process and final product release testing.
Responsible for ensuring the appropriate stability programs are initiated and completed to support product development and customer requirements.
Ensures quality control systems and equipment are compliant with standards and applicable regulatory guidelines
Responsible for ensuring that project objectives are met & continuous improvement of the Analytical Laboratories.
Strong scientific background and experience with cellular therapies across a broad range of cell types and disease treatments (adult-derived cells, stem cells, immune cells. allogeneic, autologous, etc.)
Familiarity with applicable regulatory requirements and compendia concerning cGMP manufacturing and testing of human cells (21CFR210, 211, 820 and 1271; Eudralex, USP, EP and ICH).
Understanding of analytical method qualification and validation per USP, EP and ICH guidelines.
Responsible for developing and delivering training materials to ensure that all QC employees' operational, scientific, and analytical training is conducted as needed to ensure that the group is entirely and accurately trained on time for all QC activities.
Responsible for liaison with the Manufacturing, Quality Assurance, Supply Chain, Project Management, Facilities, and other GMP Quality Control units.
Provide support in resolving issues to meet project goals and deliverables.
Serves as primary QC contact for regulatory inspections.
Leads and participates in projects within the organization's objectives and project timelines and participates in cross-functional projects as the quality control subject matter expert.
Hires, manages, and trains staff. Plans and assigns duties to meet departmental and organizational objectives. Provides guidance and direction to staff, including appropriate training, mentoring, and development of staff.
Mentor's direct reports and guide them to the next level in their careers
Is the primary point of contact and SME for analytical testing and provides guidance aligned with regulatory standards and good laboratory practices.

Qualifications:

Education/Training: Bachelor's degree in biology, biochemistry, immunology, molecular and cellular biology, or a related scientific discipline required. Advanced degree or Ph.D. in a scientific or technical discipline preferred.
Experience: 10+ years of experience in a GMP-regulated biopharmaceutical environment, including 10+ years in a management or leadership role. Experience in biologics or cell therapy preferred.
Knowledge: Strong knowledge of cGMP manufacturing and testing requirements for human cells, including 21 CFR 210, 211, 820, and 1271; EudraLex; USP; EP; and ICH guidelines. Understanding of analytical method qualification and validation per USP, EP, and ICH guidelines.
Skills: Advanced root cause investigation, troubleshooting, laboratory data evaluation, risk management, project leadership, communication, relationship-building, and team leadership skills. Proficiency with Microsoft Word, PowerPoint, and Excel required.
Certifications/Licenses: N/A

ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Apply Now

Refine Your Search

laboratory director jobs in winston salem nc

Senior Director, Quality Control

Director Analytical Research and Development

Director Analytical Research and Development

Explore jobs in cities nearby

I want to receive the latest job alert for laboratory director in winston salem nc

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected