Top 92 Associate director, compliance systems Jobs in Concord, Ca

Associate QA Operations Director - Systems and Process
Exelixis, Inc. —Alameda, CA
- $176,000 - $250,500 a year
- Email
- Computer Science
- Bachelor of Science
- Office
- Paid holidays
- Disability insurance
Associate Director of Client Services and Equity
Regional Center of the East Bay —Concord, CA
- $112,910.46 - $166,820.16 a year
- 5 years
- Adults
- Office
- Paid holidays
- Dental insurance
Quick Apply
9d
Clinical Associate Director of Support Services
The Tenderloin Housing Clinic —San Francisco, CA
- $113,964 a year
- Full-time
- In person
- Customer service
- Licensed Clinical Social Worker
- English
Associate Director of Utilization Management
Partnership HealthPlan of California —Fairfield, CA
- $162,227.25 - $210,895.42 a year
- Full-time
- Nursing
- RN License
- Word processing
2d
Associate Director, Project Management
Cumming Group —Concord, CA
- $144,300.00 - $202,033.36 a year
- Full-time
- School experience
- Bachelor of Science
- Bachelor's degree
- Paid holidays
- Disability insurance
Associate Director, Quality
Baxter —Hayward, CA
- $160,000 - $220,000 a year
- 7 years
- Engineering
- Analysis skills
- Paid parental leave
- Employee stock purchase plan
7d
ASSOCIATE DIRECTOR, AUDIT QUALITY ASSURANCE - HYBRID
University of California Office of the President —Oakland, CA
- $170,000 - $205,000 a year
- Full-time
- Hybrid work
- Background check
- CPA
- 5 years
Associate Director, Private Sector Programs (4983C), Berkeley Law - #86705
University of California Berkeley —Berkeley, CA
- $93,000 - $110,000 a year
- Full-time
- University
- Organizational skills
- Computer skills
Director, Associate General Counsel – Corporate Compliance
Form Energy, Inc —Berkeley, CA
- $235,110 - $322,955 a year
- Full-time
- Hybrid work
- Office
- Senior level
- Communication skills
- Paid parental leave
- Health insurance
Quick Apply
Associate Director, Strategic Partnerships & Client Development (4638U), Berkeley Law - #86522
University of California Berkeley —Berkeley, CA
- $105,000 - $120,000 a year
- Full-time
- Google Workspace
- Analysis skills
- Education
Associate Director, Stability Management
Exelixis, Inc. —Alameda, CA
- $172,000 - $244,000 a year
- Email
- 5 years
- Bachelor of Science
- Office
- Paid holidays
- Disability insurance
Associate Director, Regulatory Affairs (on-site)
Abbott Laboratories —Alameda, CA
- $148,700 - $297,300 a year
- Full-time
- Computer science
- Computer Science
- 5 years
- Health insurance
- Tuition reimbursement
Associate Director, Enterprise Risk Management
The Clorox Company —Oakland, CA
- $131,300 - $316,700 a year
- Full-time
- Hybrid work
- Office
- Finance
- 8 years
- Health insurance
- Adoption assistance
Associate Director, Email Marketing & Community Outreach (5372C) Intercollegiate Athletics #86698
University of California Berkeley —Berkeley, CA
- $83,000 - $90,000 a year
- Full-time
- Mid-level
- University
- Bachelor's degree
Associate Creative Director, Packaging & Print
The Clorox Company —Oakland, CA
- $109,400 - $258,500 a year
- Full-time
- Hybrid work
- Office
- 8 years
- Senior level
- Health insurance
- Adoption assistance
Associate Director, External Manufacturing and Supply
Kyverna Therapeutics —Emeryville, CA
- $160,000 - $195,000 a year
- Full-time
- Hybrid work
- Business development
- Bachelor's degree
- Travel
Associate Director, Compliance Systems
GLIDE —San Francisco, CA
- $95,000 - $115,000 a year
- Full-time
- 5 years
- System design
- Office
6d
Associate Regulatory Operations Director (Dossier Planner)
Exelixis, Inc. —Alameda, CA
- $157,500 - $222,500 a year
- Email
- 5 years
- Writing skills
- Office
- Paid holidays
- Disability insurance
Associate Director/Director, Supply Chain
Azalea Therapeutics, Inc. —Berkeley, CA
- $175,000 - $215,000 a year
- Email
- Hybrid work
- Bachelor of Science
- 8 years
- Bachelor's degree
- Health insurance
- Dental insurance
Quick Apply
Associate Director, Clinical Operations (Retina)
4D Molecular Therapeutics —Emeryville, CA
- $179,000 - $196,000 a year
- Remote
- Bachelor of Science
- Office
- 3 years

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Associate QA Operations Director - Systems and Process

Exelixis, Inc. -
Alameda, CA

Apply Now

Job Details

Full-time
$176,000 - $250,500 a year

Benefits

Paid holidays
Disability insurance
Health insurance
Dental insurance
401(k)
Flexible spending account
Vision insurance

Qualifications

Change management
Process improvement planning
Achieving project delivery timelines

Full Job Description

SUMMARY/JOB PURPOSE

The Associate QA Operations Director – Systems and Process is accountable for providing QA lead support for Quality Systems (Deviations, Change Control, CAPA, etc.), As a Partner responsible for guiding the organization in the successful, thorough, and timely execution of complex Quality Events (Deviations, Change Requests, CAPA's, CAPA Actions, Change Actions, Effectiveness Checks, etc.). Partners closely with QA and cross-functionally with Pharmaceutical Supply Chain (PSC), Clinical Development/Operations, Information technology (IT), Regulatory Affairs (RA), Global Patient Safety, etc.) as needed to identify, mitigate, escalate, and resolve issues and risks. This role supports development, generation, review, and approval of clinical and commercial artwork and labeling. Demonstrates a high level of independent quality judgment and acumen.

ESSENTIAL DUTIES/RESPONSIBILITIES

Lead and Partner QA support for Deviations, Change Control, CAPA, CAPA Actions and Effectiveness checks management.
Provide guidance on Quality systems usage, process requirements, best practices and record completeness.
Provide QA oversight of Veeva periodic enhancements (quarterly and annually).
Provide cross-functional guidance on deviations, change requests, CAPA, effectiveness checks and associated actions, supporting complete, thorough and timely completion of the quality records.
Track and trend supported systems, provide metrics for Quality Systems Management Review (QSMR).
Provide monthly Veeva Quality event status reports to QA and functional areas, proactively driving timely record closure.
Execute clinical and commercial artwork and labelling review and approval, including oversight of vendors; resolve quality issues. Deliver on company core objectives in a timely manner, per supply plan, and drive for results.
Lead process and system improvement.
Responsible for generating a risk-based strategy across the GxP landscape to identify and manage issues and risks while driving continuous improvement, to ensure compliance with global regulatory standards and align with key stakeholders.
Resolve quality issues, identify and mitigate risk, propose options and solutions, and escalate.
SME for Health Authority inspections and audits.
Establish and maintain strong collaborative relationships with internal and external stakeholders to ensure timely documentation, escalation and resolution of quality issues.
Foster collaboration within QA and stakeholders, to gain mutual trust, achieve alignment and solve problems.
Manage conflict by engaging teams to address issues, seeking diverse views and facilitating identification of options to achieve an equitable solution.
Drive results and influences others outside of direct authority.
Manage objective setting and balances commitments to prioritize and complete activities within established timelines
Performs other duties as assigned
Complies with all policies and standards

SUPERVISORY RESPONSIBILITIES

No supervisory responsibilities.

EDUCATION/EXPERIENCE/KNOWLEDGE/SKILLS & ABILITIES

Education

BS/BA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and 11 years of related experience; or,
MS/MA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and 9 years of related experience; or,
Equivalent combination of education and experience.

Experience

Experience in pharmaceutical or biotech industries, and packaging/labeling is preferred.
Experience in development of business strategies, metrics, and continuous improvements is preferred.
Proven indirect organizational and management skills, ability to manage complex issues, sound decision making and strategic skills.
Demonstrated knowledge of cGMPs, Health Authority Regulations, Quality Systems and manufacturing processes.
International/global regulatory requirements experience preferred.
Experience with participation in regulatory inspections and audits, presenting or defending functions.

Knowledge, Skills and Abilities

Required:

Apply wide range of knowledge of biotechnology/pharmaceutical sector to perform complex work, provides input beyond the QA function and proposes solutions to highly complex issues.
Understands technical information related to equipment, processes, and regulatory expectations
Demonstrate strong time-management and organizational ability to analyze and improve processes and consistently produce high quality work
Excellent written, verbal and presentation communication skills, able to translate and communicate complex concepts across all levels of the organization
Proven ability to manage multiple competing priorities, evaluate data to detect weak signals, blind spots and rapidly escalate cumulative risks
Demonstrated ability to lead through change by engaging others, assessing unforeseen situations, continuously learning to achieve a goal, and drive for results.

Travel Requirements

10% Travel time required for this position.

Environmental Requirements:

Primarily working indoors in an office environment

#LI-HG1

Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $176,000 - $250,500 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

If you have a disability and need an accommodation in relation to the application and/or recruitment process, please email us at: [email protected].

WORKING CONDITIONS:

Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.

DISCLAIMER:
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

Apply Now

Refine Your Search

associate director, compliance systems jobs in concord, ca

Associate QA Operations Director - Systems and Process

Associate Director of Client Services and Equity

Clinical Associate Director of Support Services

Associate Director of Utilization Management

Associate Director, Project Management

Associate Director, Quality

ASSOCIATE DIRECTOR, AUDIT QUALITY ASSURANCE - HYBRID

Associate Director, Private Sector Programs (4983C), Berkeley Law - #86705

Director, Associate General Counsel – Corporate Compliance

Associate Director, Strategic Partnerships & Client Development (4638U), Berkeley Law - #86522

Associate Director, Stability Management

Associate Director, Regulatory Affairs (on-site)

Associate Director, Enterprise Risk Management

Associate Director, Email Marketing & Community Outreach (5372C) Intercollegiate Athletics #86698

Associate Creative Director, Packaging & Print

Associate Director, External Manufacturing and Supply

Associate Director, Compliance Systems

Associate Regulatory Operations Director (Dossier Planner)

Associate Director/Director, Supply Chain

Associate Director, Clinical Operations (Retina)

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