Quality Assurance Senior Manager Jobs in California

Experience in in the areas of Clinical Quality Assurance, Supplier Quality Management, External Manufacturing Oversight, or Cell Therapy a plus!

Report quality system and supplier performance metrics to Quality Management Review.

Minimum 8+ years of relevant experience including pharmaceutical/biotechnology industry and Quality Assurance experience.

Excellent understanding of GxP requirements with focus on FDA and EMA

Excellent verbal and written communication skills

Generate and maintain Quality Assurance procedures and programs, ensuring alignment with FDA and EMA regulatory expectations.

You are an experienced leader who thrives on mentoring and leading others.

Oversee maintenance of current federal and state clinical laboratory accreditations, licenses, certifications, and permits.

You have a minimum of 5 years of experience in Quality Assurance/Systems in a CLIA laboratory environment.

Knowledge of LDT in a CAP-accredited and CLIA-certified laboratory is highly preferred.

Senior Manager of Quality Assurance

You work well as part of a cross-functional team and are highly adaptable to working in a fast-paced, matrix environment.

Strong technical writing and communication skills.

Work with other engineering functions for product design, development, verification, and validation.

Support the application of quality engineering/compliance of various functions and levels with technical responsibility or strategic input.

Identify and provide direction for statistical support in both design and routine manufacturing activities for achieving required levels of product reliability.

Lead the investigation, resolution, and prevention of product and process non-conformances.

Develop and conduct training when needed.

5. Experience with a Food Safety Management System in the role of Manager or Supervisor

· Program Management of all Quality Programs, e.g., cGMP, HACCP, CAPA, CCOF, Controlled Documents, Audits, etc.

· Acts as a secondary practitioner for the company’s Food Safety Management System.

· Performs audits and reporting of issues within the company’s Food Safety Management System

· Manages third party laboratory testing requirements.

3. Three (3) years of experience as a QA Laboratory Manager and/or Supervisor; AND

In-depth knowledge / experience with life science environmental monitoring management a plus

At least 10 years’ experience through increasing levels of quality management experience

Lead development of a risk management based approach to standards and systems development,support contracts and agreements and sourcing

Professional quality certification a plus: ASQ, ISO, Six Sigma, Certified Manager of Quality certification

At least 5 years’ experience directly managing reports

Experience participating in the development of opportunity assessments and loss analysis across the quality function to reduce spend and complexity

Bachelor's Degree or equivalent combination of education and experience.

5-8 years of QA experience of both web application and web service testing.

3+ years’ experience with running and developing automated test scripts.

S Degree (engineering preferred) or significant equivalent experience.

Experience developing automation code in Selenium, C#.

Experience creating, executing, and reviewing results of functional, integration, and regression testing.

Perform other duties as assigned by Management.

Identify internal requirements and external laws, regulations, guidance and standards (LRGS) applicable to one or more of division's quality systems

Interpret applicable internal requirements and external LRGS and incorporate into requirements for use in business processes internally or with external partners.

Preferred Healthcare industry and experience in quality function.

Quality Assurance experience in Medical Device manufacturing industries

Working Knowledge of applicable regulations and standards such as, FDA QSR and ISO13485

At least 3yrs leadership experience in a management/leadership position

Minimum education and experience requirements

Oversee effective management of PCI Quality Systems functions

Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.

Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules

Bachelor's Degree in a related field and/or 3-5 years related experience and/or training.

Minimum of 3 years experience in supplier quality management.

Lead the development, implementation, and improvement of supplier quality management systems, in accordance with ISO 13485 standards.

Evaluate new suppliers and implement incoming material inspections to ensure they meet established quality requirements.

Design and manage programs to reduce supplier non-conformances and improve overall supplier performance.

Proven experience and competence in quality auditing.

Strong knowledge of ISO 13485, FDA 21 CFR Part 820, ISO 14971.

Ability to manage multiple responsibilities with a high degree of self-motivation.

Demonstrated strong leadership and managerial skills.

15 years of relevant pharmaceutical experience in a Quality related position preferred.

Strong knowledge of GMP/GDP regulations and their application to both US and EU destinations.

Strong oral, written and interpersonal English communication skills.

Demonstrated planning, organizing and executions skills.

Coach others as they develop appropriate knowledge and skills through training, constructive feedback, and mentorship

Responsible for adhering to department SLAs within project management (i.e. JIRA, Confluence) and test related tools (i.e. TestRail)

High-level of gaming knowledge and/or skill

Ensure requirements and risks are continually either mitigated or accepted throughout the SDLC

Advocate for the user experience through delivery of qualitative reporting

Bachelor’s degree in related field or equivalent experience