14 Best director of manufacturing jobs in Fremont, CA (Hiring Now!)

Director, Quality Assurance
Revance —Newark, CA
Furthermore, the role will provide quality assurance management support to the cross-functional CMC teams and ensuring compliance with cGMP requirements (US and…
$187,000 - $244,000 a year
Sr. Director, Production Print
Konica Minolta Business Solutions, U.S.A., Inc. —San Ramon, CA
Bachelor's degree in a related field. Assist in developing sales and/or production print technical sales support process and generate performance reviews.
Estimated: $114K - $145K a year
3d
Director, Small Molecule Analytical Development, Analytical Development and Operations (ADO)
Gilead Sciences —Foster City, CA
Applies global scientific guidelines to develop strategy to ensure continued clinical and marketing application approval successes.
$221,170 - $286,220 a year
Director of Manufacturing Operations
Confidential —Fremont, CA
Requires a BSEE/BSME or equivalent in an Engineering field. Within these endeavors, the Director of Operations must manage, mentor and implement a manufacturing…
From $150,000 a year
Quick Apply
9d
Director of Manufacturing Engineering
Mizuho OSI —Union City, CA
Bachelor’s degree in electrical engineering, mechanical engineering, or related field. Collaborate with other Mizuho engineers on electro-mechanical designs,…
$161,810.60 - $231,158.00 a year
2d
Director of Quality
Nevados —Oakland, CA
Discussions with Hiring Managers: In-depth calls with hiring managers/team members to assess your technical skills and fit. 3+ years in a supervisory role.
$130,000 - $180,000 a year
Quick Apply
9d
Director of Quality Assurance, Tioga Cardiovascular
Shifamed —Los Gatos, CA
7+ years Quality or technical Management experience in the medical device or a related field. Coordinate attention to customer complaints, corrective actions,…
$180,000 - $220,000 a year
Quick Apply
Director Quality Assurance
Abbott Laboratories —Pleasanton, CA
The Director of Quality Assurance leads management team and technical staff of multiple groups/functions within business unit/product specific division Quality…
$186,300 - $372,700 a year
Director, Quality Assurance
Taiho Oncology, Inc. —Pleasanton, CA
Solid experience in GCP Quality assurance (e.g, previously conducted inspection readiness, successful inspection outcome and experience with health authority…
$185,000 - $218,000 a year
Quick Apply
5d
Associate Director, Quality Improvement
Elwyn —Fremont, CA
Must have current, valid driver's license in state of residence, three (3) years driving experience in the United States, and acceptable driving record.
Estimated: $68K - $86.1K a year
6d
Director/Sr. Director, CMC Quality Control
Rani Therapeutics —San Jose, CA
Support continuous collaboration with manufacturing, technical operations, manufacturing, QA, regulatory affairs, clinical development, and program management,…
$200,000 - $255,000 a year
Quick Apply
5d
Director, Quality Assurance Compliance/Auditor
Gilead Sciences —Foster City, CA
Promote, awareness across the biologics commercial and clinical manufacturing platform(s) of current regulatory agency requirements and trends and develop and…
$205,700 - $266,200 a year
2d
Senior Director, Quality Assurance Compliance
IDEAYA Biosciences —South San Francisco, CA
Develop, implement and manage inspection readiness activities to support regulatory inspections and partner audits.
$260,000 - $272,000 a year
Director, SAP Architect - Industrial Manufacturing
KPMG —San Jose, CA
Excellent communication skills, able to articulate complex technical concepts to a non-technical audience. KPMG does not currently require partners or employees…
Estimated: $179K - $227K a year

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Director, Quality Assurance

Revance - Newark, CA

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Job Details

$187,000 - $244,000 a year

Benefits

Health savings account
Health insurance
Unlimited paid time off
Tuition reimbursement
Parental leave
401(k) matching

Qualifications

Biotechnology
Management
Doctoral degree
Master's degree
Supervising experience
Quality assurance
Bachelor's degree
Mentoring
Senior level
4 years
Leadership
Communication skills

Full Job Description

Job Summary:

The Director, Quality Assurance is responsible for QA oversight of internal and external operations in support of Revance commercial and clinical products. Furthermore, the role will provide quality assurance management support to the cross-functional CMC teams and ensuring compliance with cGMP requirements (US and EU), in-house SOPs and standards both in-house and to Revance's third party contractors as it relates to manufacturing and testing of the raw materials and products. The individual will manage, develop, and train QA personnel and write performance reviews.

Reporting to: Executive Director, Quality Assurance & Validation

Location/Territory: Newark, CA

Salary Range: $187,000 to $244,000

Responsibilities/Essential Duties:

Provide quality assurance oversight for production, testing and release of clinical and commercial products manufactured in-house or by CDMOs
Provide quality assurance oversight for production, testing and release of packaging activities at 3PL vendor(s)
Responsible for lot dispositions of Revance commercial and clinical products
Responsible for release of raw materials (e.g., chemicals, packaging and labeling components, etc.), including incoming quality attribute inspections and retain sampling
Responsible for establishing and maintaining quality agreements for key Suppliers
Responsible for monitoring of quality performance and issue resolution for Suppliers (including monitoring of quality agreement parameters)
Provide QA oversight for Process, Cleaning, and Shipping Validation
Implement and maintain programs and processes to ensure high quality products and compliance with cGMPs and GLPs
Organize and prioritize group tasks, provide job skills training and mentoring of personnel
Review and approve documents such as standard operating procedures, manufacturing batch records, packaging and labeling records, sampling plans, test methods, specifications, and protocols and reports for method validations and stability studies
Act as a compliance resource to provide guidance and assistance around aseptic processing and towards resolution of complex deviations, quality investigations, lab investigations, CAPAs and change control; review and approve quality system documents related to manufactured products
Ensure consistent quality standards across multiple CDMOs, CTLs, and 3PLs
Responsible for QA reserve sample management
Responsible for Annual Product Review Program
Responsible for Recall and Biologics Product Deviation Programs
Conduct Quality Review Board meetings
Maintain product quality assurance performance metrics
Support regulatory agency inspections or third party audits by participating in inspection preparation and assisting the inspection strategy room.

Basic Qualifications:

Doctorate degree & 5 years of Quality Assurance experience

Master's degree & 7 years of Quality Assurance experience

Bachelor's degree & 9 years of Quality Assurance experience

AND

4 years of managerial experience directly managing people, projects, programs or resources

Preferred Qualifications:

10 plus years of experience in the pharmaceutical or biotechnology industry
5 plus years of those years in QA
5 plus years in management and/or supervisory role
Comprehensive expertise and working knowledge of 21 CFR Parts 201, 211, 820, Eudralex Volume 4 and related Annexes, and ICH guidance documents
Experience of working with CDMOs
Experience working in and with different people and organizational cultures, supporting people with diverse backgrounds, attitudes and cultural differences
Strong interpersonal, analytical, organizational and leadership skills
Excellent written and verbal communication
Ability to handle multiple time constrained projects simultaneously

Company Summary:

As a commercial-stage biotechnology company focused on innovative aesthetic and therapeutic offerings, Revance is setting the new standard for its clients through disruptive products, and for its employees through industry-leading benefits, which promote financial and physical well-being for all. It's time to rethink everything you thought an employee experience could be.

What Revance invests in you:

Competitive Compensation including base salary and annual target bonus
Flexible unlimited PTO, summer & winter shutdowns, and 12 weeks parental leave
Generous healthcare benefits (Company pays up to 90% of premiums for medical benefits), Employer HSA contribution, 401k match, tuition reimbursement, wellness discounts and much more

Note: Revance has agreed to merge with Crown Laboratories. Upon completion of this merger, benefits are subject to change.

This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a "qualified individual with a disability" in all aspects of the employment relationship. A "qualified individual with a disability" is "an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job."

We are an equal opportunity employer. We are a company where diverse backgrounds, experience and viewpoints are valued. Revance does not discriminate in practices or employment opportunities on the basis of an individual's race, color, national or ethnic origin, religion, age sex, gender, sexual orientation, marital status, veteran status, disability, or any other prohibited category set forth in federal or state regulations.

Apply Now

director of manufacturing jobs in Fremont, CA

Director, Quality Assurance

Sr. Director, Production Print

Director, Small Molecule Analytical Development, Analytical Development and Operations (ADO)

Director of Manufacturing Operations

Director of Manufacturing Engineering

Director of Quality

Director of Quality Assurance, Tioga Cardiovascular

Director Quality Assurance

Director, Quality Assurance

Associate Director, Quality Improvement

Director/Sr. Director, CMC Quality Control

Director, Quality Assurance Compliance/Auditor

Senior Director, Quality Assurance Compliance

Director, SAP Architect - Industrial Manufacturing

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