Senior Director Quality Jobs in California

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

Accountable for management and maintenance of program for sterilization qualification, shipping/transport studies, packaging, and shelf life.

Accountable for maturation of existing quality systems for risk management and validation.

Program-level experience with validation or equivalent verification/validation, or qualification

Skills/ Abilities Pertinent To This Position

Experience leading and mentoring staff and colleagues

Able to perform analysis to support material selection and qualification of pharmaceutical-grade materials

Assure business continuity in leadership positions and critical roles through talent management planning and development.

Must be articulate and able to communicate effectively with Corporate Officers, DVPs, directors, managers and employees across the corporation.

Possess substantial knowledge of FDA/International guidelines for device.

Career development with an international company where you can grow the career you dream of

Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

An excellent retirement savings plan with high employer contribution

Minimum three (3) years program management/supervisory experience.

Total Quality Management certification or Certified Professional of Healthcare Quality (CPHQ) preferred.

Mitigates medical/legal liability through development of a program which links risk management activities with those of continuous performance improvement.

Demonstrated knowledge of governmental accreditation and other regulatory standards, requirements, and guidelines related to quality performance.

Must be able to work in a Labor/Management Partnership environment.

Determines strategy for changing existing processes to meet regulatory requirements and translating external demands into program goals.

Prior experience and knowledge in implementing Quality Management System and electronic document control systems.

Direct development, initiation, and maintenance of all Quality Systems in support of the product(s) including the Quality Management Review.

Competence in FDA and international GMP requirements. Strong working knowledge of GCP beneficial.

Manage external consultants, as required.

Minimum of ten (10) years of Quality Assurance experience in FDA regulated industry, preferably, biologic or Antibody Drug Conjugate therapeutics.

Prior experience with IND and early clinical stage oncology programs.

Knowledge of regulatory requirements a plus

Exceptional written and verbal communication skills.

Prioritization and negotiation skills managing quality issues with suppliers.

Extensive knowledge o the beauty industry a plus

Minimum of 5 years quality experience.

Quality audits of third party manufacturers (TPM)

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.

Acts as the Quality Management Representative for regulatory authorities

May perform additional duties as assigned or directed by management from time to time.

Bachelor’s degree in life science or related field or the equivalent combination of education and/or experience. Engineering degree preferred.

Effective manager with ability to mentor and develop members of the QA/RA teams through coaching and effective performance management.

Manages the review and approval of finished products manufactured for and by the company in accordance with their approved specifications.

Manages product recall activities to include recall policies and procedures for the company.

Deep knowledge and understanding of GxP and regulatory requirements

Manage and provide leadership to Quality team members including on Quality Assurance, Quality Systems, and Quality Control.

Experience with operational process improvement initiatives

Excellent foundational skills including strong analytical, written and verbal communication skills, compelling facilitation and presentation skills.

Annual L&D stipend for conferences, continuing education, etc.

In return, we offer a supportive environment. We value: