Top 90855 Director Quality Systems Jobs

Director, Quality Assurance (Quality Systems)
Syncromune —Remote
- $210,000 - $230,000 a year
- Full-time
- 5 years
- Travel
- Senior level
Quick Apply
Director, Engineering Controls (SSI)
Shermco Industries, Inc. —Wichita Falls, TX
- $162,000 - $240,000 a year
- Full-time
- 11+ years
- Master's degree
- Mentoring
Quick Apply
Respiratory Therapist Lead
Northfield Hospital & Clinics —Northfield, MN
- $39.48 - $55.73 an hour
- 8 hour shift
- Management
- PALS Certification
- Hospital
- Free parking
- AD&D insurance
Quick Apply
Athletic Trainer - MWSU
Mosaic Life Care —Saint Joseph, MO
- Weekends as needed
- Mid-level
- Master's degree
- Driver's License
- Free parking
Medical Director
Bethel Family Clinic Inc. —Bethel, AK
- $175,000 - $250,000 a year
- Full-time
- Background check
- Nursing
- Medicine
- Loan repayment program
- Relocation assistance
Quick Apply
Medical Director
Care Alliance Health Center —Cleveland, OH
- $202,000 - $215,000 a year
- Full-time
- Medicine
- Acute care experience
- Senior level
- Paid holidays
- Health insurance
Quick Apply
6d
Medical Director
Wyandot Behavioral Health Network —Kansas City, KS
- Full-time
- Background check
- Medicine
- Psychiatry
- Health savings account
- Loan repayment program
Quick Apply
13d
Medical Laboratory Scientist or Technician
St. Charles Health System —Redmond, OR
- $29.37 - $55.49 an hour
- Part-time
- Doctoral degree
- Customer service
- Mid-level
Clinic Medical Director - VA employees welcome
Valor Healthcare, Inc. —Williston, ND
- $300,000 - $320,000 a year
- Medicine
- Computer literacy
- BLS Certification
- Continuing education credits
- Health insurance
Quick Apply
Respiratory Therapy Manager
Carlsbad Medical Center —Carlsbad, NM
- Full-time
- BLS Certification
- ACLS Certification
- Master's degree
- Health insurance
- Dental insurance
Quick Apply
Director OSP Construction
Lightpath Fiber —Plain City, OH
- Weekends as needed
- Background check
- Clean driving record
- Oracle
Albany CT Technologist
Mosaic Life Care —Albany, MO
- Full-time
- Hospital
- Customer service
- BLS Certification
- Free parking
Cytogenetics Laboratory Supervisor
WVUH West Virginia University Hospitals —Morgantown, WV
- Full-time
- Ability to sit for extended periods
- Pediatrics
- Pediatrics
Director of Rehabilitation (DOR)
Lodi Nursing & Rehabilitation —Lodi, CA
- $120,000 - $160,000 a year
- Full-time
- CPR Certification
- Skilled nursing facility
- OSHA
- Disability insurance
- Health insurance
Quick Apply
Nursing Director - Inpatient Services
Eastern New Mexico Medical Center —Roswell, NM
- Full-time
- Nursing
- RN License
- BLS Certification
- Health insurance
- Dental insurance
Quick Apply
Clinic Medical Director
Valor Healthcare, Inc. —Copperas Cove, TX
- $260,000 - $280,000 a year
- Medicine
- Computer literacy
- BLS Certification
- Relocation assistance
- Health insurance
Quick Apply
Physician Medical Director (Sign-on Bonus, Work-life Balance, Competitive Total Compensation)
InnovAge —Sacramento, CA
- $371,000 - $415,000 a year
- Email
- Bilingual
- Background check
- Medicine
- AD&D insurance
- Paid holidays
Medical Director
Missouri Ozarks Community Health —Ava, MO
- $265,000 - $280,000 a year
- Online Application
- Background check
- Medicine
- Doctoral degree
- Paid holidays
- Relocation assistance
Quick Apply
Clinic Medical Director
Valor Healthcare, Inc. —San Antonio, TX
- Medicine
- Computer literacy
- BLS Certification
Quick Apply
Director of Quality Initiatives & Compliance
Dental Associates —Savage, MN
- $120,000 - $140,000 a year
- Full-time
- Dental office
- HIPAA
- Office
- Health savings account
- Health insurance
Quick Apply

I want to receive the latest job alert for Director Quality Systems

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

Director Quality Systems jobs near

Clinical Director jobs in San Antonio, TX

Director Of Nursing jobs in Roswell, NM

Medical Director jobs in Cleveland, OH

Director Of Quality Assurance jobs in Remote

Medical Director jobs in Sacramento, CA

Respiratory Therapist jobs in Northfield, MN

Medical Director jobs in Kansas City, KS

Director Of Construction jobs in Pennsylvania

Director Of Construction jobs in Oklahoma

Youth Program Director jobs in Chicago, IL

Director Of Construction jobs in Seattle, WA

Director Of Construction jobs in Omaha, NE

Athletic Director jobs in Rochester, NY

Director Operations Healthcare jobs in Georgia

Director Of Engineering jobs in Denver, CO

Director Of Engineering jobs in Bethlehem, PA

Director Of Engineering jobs in Overland Park, KS

Director Of Engineering jobs in Raleigh, NC

Early Childhood Director jobs in Los Angeles, CA

Clinical Director jobs in Washington, DC

Director, Quality Assurance (Quality Systems)

Syncromune
Remote

Quick Apply

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.

JjjSv2Knje

Quick Apply

Refine Your Search

Director Quality Systems jobs

Director, Quality Assurance (Quality Systems)

Director, Engineering Controls (SSI)

Respiratory Therapist Lead

Athletic Trainer - MWSU

Medical Director

Medical Director

Medical Director

Medical Laboratory Scientist or Technician

Clinic Medical Director - VA employees welcome

Respiratory Therapy Manager

Director OSP Construction

Albany CT Technologist

Cytogenetics Laboratory Supervisor

Director of Rehabilitation (DOR)

Nursing Director - Inpatient Services

Clinic Medical Director

Physician Medical Director (Sign-on Bonus, Work-life Balance, Competitive Total Compensation)

Medical Director

Clinic Medical Director

Director of Quality Initiatives & Compliance

I want to receive the latest job alert for Director Quality Systems

Related Searches

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected