Senior Director Quality Assurance Jobs in Alameda, California

Ensures adherence to change management process and support validation activities such as development of user requirements, protocols and reports.

Leads Quarterly Management Reviews with the executive team.

Ability to make risk-based and phase appropriate decisions and effectively communicate risks to management.

Leads internal audits, customer audits as well as surveillance and certification audits by our notified body to ensure compliance.

Strong verbal and written communication skills and ability to navigate stakeholders from various departments.

Requires knowledge of ISO 9001 and/or ISO 13485, 21 CFR 820, or ICH Q7.

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

Participate in and provide QA direction in development program planning and management meetings.

Responsible for maintaining current knowledge of applicable compliance requirements through attendance at industry and regulatory agency sponsored meetings and seminars.

BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent combination of education and experience

Manage QA consultants and other external vendors, including organizing and prioritizing group tasks, performing training; expand QA department, as needed.

12+ years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices

Strong interpersonal, communication, teamwork, and analytical skills

Collaborate with cross-functional teams, including development, product management, and customer support, to drive quality initiatives.

Present regular quality status reports to senior management, highlighting areas of concern and improvement opportunities.

Recruit, mentor, and manage a high-performing QA team, providing coaching and professional development opportunities.

Foster a collaborative and inclusive team environment that encourages open communication and knowledge sharing.

Experience with test automation tools and frameworks.

Excellent communication, leadership, and interpersonal skills.

Sekisui Diagnostics offers a competitive compensation.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

To be successful in this role

Oversees and leads quality and compliance risk management initiatives to minimize risk and potential impact of quality and/or non-compliance events

Provide leadership in global issue management (GIM) including product complaints and product recall process management and reporting.

Extensive knowledge and experience in GMP, GCP and GDP global regulations, principles, concepts, practices, and standards.

Demonstrated ability to work effectively in a matrix environment and drive results through “influence” as well as direct management

Develop and manage department budgets and long-range plans for the team.

15+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other highly regulated industry

Manage an effective quality assurance program that monitors for and resolves issues before they become problems.

Arrange staff training on a regular and ongoing basis. Ensure project training program meets all corporate requirements.

7+ years relevant professional experience required.

Experience in leading Quality Operations

Oversee the day-to-day functions of the Quality Assurance (QA) department.

Supervise the development and regular update of policies and procedures.

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

·Experience in cleaning validation, process validation and supply chain management.

C.) Thorough knowledge of 21 CFR 820.

F.)Experience in USFDA and ISO auditing and ability to lead team to successful audits.

G.) Experience with designing and developing test cases based upon system specifications.

· Minimum 5-7 years of experience in leading company to maintain GMP, ISO and FDA Regulations

4.) Directs and enforces GMP’s, GLP’s, and safety policies.

Demonstrated experience and success in staff management and creating a collaborative and positive work environment.

Possess strong time management and organization skills (must be able to multi-tasks).

Initiate and improve company-wide efforts to improve customer service experience.

Manage activities (including vendors/suppliers) to ensure continuous control over materials, facilities, services and products.

8-10 years demonstrated experience in overseeing Quality Assurance/Engineering department for small to mid-sized PCB organization.

Knowledge and understanding of PCB manufacturing technologies.

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.

Experience in supplier management and relations, including quality agreement generation and maintenance

Thorough of design control principles and risk management (FMEA and Hazard Analyses)

Demonstrate excellent interpersonal communication skills, which enable you work with multiple BD business units.

Ability to communicate ideas and knowledge effectively and clearly to other individuals, teams and customers.

Quality Engineering experience or 12+ years industry experience (Healthcare/ Pharmaceutical)

Good written and oral communication skills

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.

Strong project management and presentation skills.

Comprehensive knowledge of quality assurance and compliance with Food and Drug Regulations and associated cGMP compliance requirements.

Required Skills and Capabilities you’ll need to have:

Good critical and deductive reasoning, and agile decision-making skills.

Comprehensive knowledge of manufacturing operations, GMP’s, GLP’s, SOPs, auditing, and inspection.

Strong people development and leadership skills

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

Experience working with CMOs, vendor selection, and management

Develop, improve, and maintain quality management systems, policies, and SOPs

Good knowledge or experience in Aseptic processing

Manage, track, and trend quality systems and establish metrics

Support and review protocols and reports for Tech-Transfer, Qualification, and Validation activities

Minimum of 6 years of pharmaceutical industry experience in QA

Drive improvements on efficiency of management systems and functionality

Six Sigma Green or Black Belt Certification

10+ years experience in Quality and 5+ years leadership in Quality

The Responsibilities of the QA Director include:

The Qualifications of the QA Director Include:

Leading quality efforts in new product design and give direction on driving continuous improvement efforts

Deep knowledge of Quality Systems Management

5+ years in a leadership or management position

Establishes and implements quality systems, programs, policies, processes, procedures, and controls according to established standards and regulatory requirements.

Ensures quality oversight across the organization by balancing risk-based approaches with compliance and phase-appropriate development capabilities.

Develop, implement, and manage a risk-based quality governance and oversight program in compliance with cGXP quality systems.

Establish internal and/or external QC testing capabilities to support in-process, release, and stability testing programs.

Experience with electronic Quality Management Systems and Trial Master File.

Experience in crafting and implementing quality systems and risk management tools.

Strong teamwork, collaboration and management skills.

Participate in the recruitment, performance, and management of staff in Clinical QA, including coaching, career development and oversight of work.

Effectively communicate compliance related metrics, risks, and compliance challenges to senior management.

Proven, extensive knowledge of worldwide GCP regulatory requirements, industry practices, and ability to apply concepts.