Top 128201 Director, Quality Assurance Jobs

Director, Quality Assurance (Quality Systems)
Syncromune —Remote
- $210,000 - $230,000 a year
- Full-time
- 5 years
- Travel
- Senior level
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Director, Engineering Controls (SSI)
Shermco Industries, Inc. —Wichita Falls, TX
- $162,000 - $240,000 a year
- Full-time
- 11+ years
- Master's degree
- Mentoring
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Amberwell Health Hiawatha —Hiawatha, KS
- Weekends as needed
- Nursing
- RN License
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Clinical Director
Confidential —Anchorage, AK
- $100,000 - $125,000 a year
- Full-time
- LMFT
- 5 years
- Licensed Clinical Social Worker
- Relocation assistance
- Health insurance
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Thoma-Sea Marine Constructors, LLC —Houma, LA
- $18 - $23 an hour
- Full-time
- High school
- 5 years
- Computer literacy
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Metal Fabricating Quality Manager
FabCon LLC —Nesbit, MS
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- Full-time
- Microsoft Outlook
- 3 years
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Director, ICU/Pathology - SMG
SMG System Medical Group —Morgantown, WV
- Overtime
- Hybrid work
- Hospital
- Urgent Care
- Master's degree
Quality Engineer
Jones Plastic & Engineering Co., LLC —Williamsburg, KY
- $55,000 - $60,000 a year
- Full-time
- Background check
- Computer literacy
- Mid-level
- Health insurance
- Dental insurance
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Director of Quality - Great Falls Montana
Avmax Montana, Inc. —Great Falls, MT
- Full-time
- Background check
- Microsoft Excel
- Pass drug screening
- Health savings account
- Health insurance
Associate Medical Director - Primary Care
Southwest CARE Center —Santa Fe, NM
- Full-time
- Primary Care
- Clinic
- Senior level
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RN Quality Assurance Coordinator
Elite Home Health —Hobbs, NM
- Full-time
- RN License
- Home Health
- Patient care
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Quality Control/Site Safety Health Officer
Cheroenhaka Nottoway Enterprises, LLC (CNE) —Chantilly, VA
- Full-time
- Carpentry
- Background check
- CPR Certification
- Health insurance
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Quick Apply
APQP Quality Engineer
Crane Aerospace & Electronics —Elyria, OH
- Full-time
- Background check
- Microsoft Excel
- Microsoft Outlook
- Paid holidays
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Director of Quality Assurance Substance Abuse Disorder Services
Fusion Recovery Centers LLC —Albany, NY
- $85,000 - $95,000 a year
- Full-time
- Hybrid work
- Background check
- Addiction Medicine
- Quality control
- Health insurance
- Dental insurance
Quick Apply
Director of Engineering
GenSystems —Houston, TX
- Extended hours
- Construction site
- Customer service
- 5 years
- Health savings account
- Health insurance
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Medical Director
Delaware Valley Residential Care —Warminster, PA
- $2,500 - $3,500 a month
- Full-time
- Medicine
- Management
- Doctoral degree
- Health insurance
- Dental insurance
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Materials Quality Assurance Inspector
Sterling —Anchorage, AK
- Full-time
- Microsoft Word
- English
- Mid-level
- Health savings account
- Health insurance
Director of Operations
Ramsey Companies, Inc. —Wapato, WA
- From $150,000 a year
- Full-time
- Clean driving record
- Inventory control
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- Fuel card
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Quality Engineer
Izzio Artisan Bakery LLC —Thornton, CO
- $75,000 - $85,000 a year
- Weekends as needed
- Mid-level
- Analysis skills
- Bachelor's degree
- Paid holidays
- Health insurance
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Bilingual Spanish /English Afternoon Quality Control Supervisor
Pivot Staffing, LLC —Sterling Hts, MI
- From $21 an hour
- Full-time
- Mid-level
- Analysis skills
- Organizational skills
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Director, Quality Assurance (Quality Systems)

Syncromune
Remote

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Job Details

Full-time
$210,000 - $230,000 a year

Qualifications

Staff supervision
GxP
Team leadership
Pharmaceutical regulatory compliance
Enterprise software
Professional ethics
Drug regulation
Enterprise solutions implementation
Team development
ICH guidelines
Pharmaceutical company experience
Industry trends
Quality assurance experience within pharmaceutical industry
Vendor communication
Biomedical regulatory compliance
Managing projects
Video conferences (communication methods)
Managing product quality assurance teams
Project leadership
Technical Proficiency
Cross-functional communication
FDA regulations
Team building

Full Job Description

The Director, Quality Assurance (Quality Systems) will be primarily responsible for the implementation and maintenance of Phase-appropriate Quality processes and procedures in accordance with Good Industry Practices (GXP) for Syncromune’s programs and products. The Director, QA (Quality Systems) will continue to build and cultivate GXP through organizational processes, including training programs and implementation and management of the electronic Quality Management System (eQMS) for the Drug division.

This role will serve as the primary interface and administrator for the Pharmaceutical Quality System (PQS) at Syncromune, with responsibility for establishing conformance to quality system requirements and ensuring system-level alignment with vendor, supplier, and CDMO quality activities. The role will lead the project team for the implementation of Syncromune’s electronic Quality Management System (eQMS).

Principal Duties and Responsibilities include the following:

Lead administration and continuous improvement of Syncromune’s global Pharmaceutical Quality System (PQS), focusing on quality processes and infrastructure that support the company’s progression from startup to commercial operations. Enable compliant scalable growth across programs, sites and geographies in accordance with applicable regulations and standards.
Serve as Business Owner, Administrator, and Subject Matter Expert (SME) for the PQS and eQMS, including system level elements such as Document Control, Training, Deviation Management, Risk Management, CAPA, Change Management, Internal Audit, External Audit support, Vendor/Supplier Quality Systems Requirements, and the quality system components of Pharmacovigilance, Product Surveillance/ Complaints, and Recalls, while coordinating with Quality Management for operational and product-level activities.
Lead the evaluation, validation, implementation, and administration of an electronic Quality Management System (eQMS).
Manage the internal audit program.
Support and co-host GXP-focused audits, inspections, and assessments of Syncromune in partnership with Quality Management for auditors including, but not limited to:
- Notified Bodies
- Regulatory Authorities
- Customers
- Potential partners
Partner with Supplier Quality Management, Drug Development, and other internal functions to ensure alignment between PQS requirements and external manufacturing quality activities, maintaining clear process ownership between system-level QA and operational QA.
Build and develop a high performing team to support and advance Syncromune’s business objectives.

Supervisory Responsibilities:

Direct reports: to be defined as the team grows.

Qualification Requirements:

Education:

Bachelor's degree in Life Sciences, Engineering, Medical Technology, or related scientific discipline required. Advanced degree preferred.
Professional certifications such as ASQ Certified Quality Auditor (CQA), Regulatory Affairs Certification (RAC), or other GXP certification a plus.

Experience:

Approximately 10 years of progressively responsible experience in quality assurance within the pharmaceutical or biotechnology industry.
At least 5 years of experience in a leadership or management role of a PQS with direct report responsibilities.
Positive experience in hosting and managing regulatory authority inspections and completing remediation activities.
Demonstrated success in leading the implementation of an electronic Quality Management System (eQMS).

Knowledge/Skill:

High degree of technology proficiency and fluency in Enterprise platforms.
Excellent project management skills with ability to manage multiple priorities in a fast-paced environment.
Commitment to integrity, ethics, and quality culture development.
Expertise in the US FDA Code of Federal Regulations and International Council on Harmonisation (ICH) as applicable to the pharmaceutical industry.
Exceptional leadership abilities with proven success building and motivating high-performing teams as well as turnaround teams.
Outstanding written and verbal communication skills with ability to influence at different functional and organizational levels both internally and with Vendor/ Contractor/ Supplier partners.
Demonstrated ability to work collaboratively across functions and across geographies, and skill in building effective partnerships for successful outcomes.
Proactive mindset, driving projects forward and providing recommendations to Leadership based on anticipated compliance challenges and industry trends.

Working Conditions:
Specify work environment:

The work environment is remote, and must be in a suitable location that allows focused output and video meetings.
Domestic travel may be required up to 10% of time.
This role requires a high degree of computer screen time and the individual will be regularly required to see, talk, hear, read, and type.

Syncromune is an Equal Opportunity Employer.

Expected US salary range: $210,000-$230,000

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to, the primary work location and the chosen candidate’s relevant skills, experience, and education.

This position generally is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under the Company’s benefit plans.

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Refine Your Search

Director, Quality Assurance jobs

Director, Quality Assurance (Quality Systems)

Director, Engineering Controls (SSI)

Director of Emergency Care

Clinical Director

QC Inspector

Metal Fabricating Quality Manager

Director, ICU/Pathology - SMG

Quality Engineer

Director of Quality - Great Falls Montana

Associate Medical Director - Primary Care

RN Quality Assurance Coordinator

Quality Control/Site Safety Health Officer

APQP Quality Engineer

Director of Quality Assurance Substance Abuse Disorder Services

Director of Engineering

Medical Director

Materials Quality Assurance Inspector

Director of Operations

Quality Engineer

Bilingual Spanish /English Afternoon Quality Control Supervisor

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