QA Manager (GLP bioanalytical)

InnoAlliance Inc; San Jose (CA); On-site; USD 119,000 - 162,000; Full time

Job summary

Join a forward-thinking Contract Research Organization as the Site Head of the US Bioanalytical Lab. In this pivotal role, you will lead the establishment of quality systems that ensure compliance with Good Laboratory Practices (GLP). Your expertise will help manage Bioanalytical GLP QA activities, conduct audits, and prepare for client inspections. This position offers an exciting opportunity to work with a passionate team committed to delivering top-tier bioanalytical services to a diverse range of clients, from large pharmaceuticals to innovative startups. If you thrive in a fast-paced environment and are eager to make a significant impact, this role is for you.

Qualifications

• 5+ years in Bioanalytical GLP pharmaceutical industry.
• Strong knowledge of GLP requirements and quality functions.

Responsibilities

• Lead GLP quality systems for laboratory testing services.
• Manage Bioanalytical GLP QA activities and client inspections.

Skills

GLP Compliance

Quality Assurance

Leadership

Communication Skills

Document Review

Education

B.S. Degree in a related field

Advanced Degree (preferred)

Tools

MS Office

Quality Management Systems

Watson LIMS

Job description

3 days ago Be among the first 25 applicants

Direct message the job poster from InnoAlliance Inc

Site Head of US Bioanalytical Lab | GLP, Ligand Binding Assays

InnoAlliance is a Contract Research Organization (CRO) providing top tier quality bioanalytical services. We aim to partner with all companies that need bioanalytical support, from multinational pharmaceuticals to mid- and small-size biotech companies including startups and virtual companies. Our service areas range from standard biomarker testing to customized PK/ADA method development and validation. We are looking for an experienced GLP QA manager to join our passionate team to partner with our clients for success.

Role and Responsibilities

· Lead the efforts establishing and administering the quality systems supporting Good Laboratory Practice (GLP) compliant nonclinical and clinical laboratory testing services. Assure the lab management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance of FDA and various regulations.

· Manage and ensure all the activities related to Bioanalytical GLP QA activities are completed as required

· Host client and regulatory inspections including preparing responses of findings if any. Establish and maintain a state of inspection readiness including site specific folders

· Perform periodic audits of data packages. Review and approve protocols and reports for GxP studies with an emphasis on GLP studies

· Evaluate studies in determination of root cause and assess quality impact

· Recommend CAPA’s and follow-up to ensure CAPA’s implemented are effective

· Perform training throughout the organization as needed

· Work with clients and senior management to develop QA project plans

· Review non-conformance events, log books, procedures, and training as needed

· Write SOPs, reports, and conduct document reviews

Qualifications and Education Requirements

· Minimum of 5 years of experience in the Bioanalytical GLP pharmaceutical/biopharmaceutical industry with a minimum of a B.S. Degree. Advanced degrees are preferred

· Previous technical experience in the areas of chemistry, biochemistry, or biology is highly preferred

· Must possess a working knowledge of GLP requirements and other policies/regulations as applicable. Experience working in bioanalytical CRO space is preferred

· Must possess a conceptual understanding of all Quality functions and business areas

· Must have the ability to function in a fast-paced environment and communicate effectively with senior management

· Great leadership experience in both project and people management

· Excellent communication, interpersonal, organizational, and multi-tasking skills.

· Ability to work independently and pay good attention to the details.

Preferred Skills

· Proficient in MS Office, Quality Management Systems, Watson LIMS, etc.

Additional Notes

• · InnoAllience 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 protected veteran, among other things, or status as a qualified individual with disability.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

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