Top 20 Senior manager quality Jobs in Ashburn, Va

Senior Manager, Quality Systems & Compliance
MacroGenics —Rockville, MD
- $137,700 - $210,000 a year
- Call employer
- 5 years
- Bachelor's degree
- Team management
- Paid parental leave
- Employee stock purchase plan
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Senior Program Quality Manager
MANTECH —Herndon, VA
- Full-time
- 11+ years
- Office
- Master's degree
Senior Technical Program Manager, Infrastructure Reliability and Quality (IRQ)
Amazon Data Services, Inc. —Herndon, VA
- $148,700 - $201,200 a year
- Full-time
- 7 years
- Senior level
- Electrical Engineering
- AD&D insurance
- Health insurance
National Tax Senior Manager - Quality Assurance and Risk Management
CohnReznick —Tysons Corner, VA
- $150,000 - $250,000 a year
- Remote
- 7 years
- CPA
- Research
- Paid time off
- Parental leave
Quality Assurance Manager - Senior
Enterprise Solutions & Management Corporation —Vienna, VA
- $140,000 - $165,000 a year
- Full-time
- 5 years
- Research
- Office
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12d
Senior Manager Quality
Leonardo DRS —Germantown, MD
- $134,332 - $181,349 a year
- Full-time
- 7 years
- Writing skills
- Engineering
- Paid parental leave
- Health savings account
11d
Senior Director, Quality
ATCC —Manassas, VA
- Full-time
- 18 years or older
- 11+ years
- Master's degree
- 403(b) matching
- Paid parental leave
Sr. Reliability Technical Program Manager, Infrastructure Reliability & Quality
Amazon Data Services, Inc. —Herndon, VA
- $148,700 - $201,200 a year
- Full-time
- Computer Science
- 5 years
- Engineering
- AD&D insurance
- Health insurance
Sr. Reliability Product Manager-Tech, Infrastructure Reliability & Quality
Amazon Data Services, Inc. —Herndon, VA
- $151,200 - $204,600 a year
- Full-time
- 5 years
- Writing skills
- Engineering
- AD&D insurance
- Health insurance
Sr Director, Quality Engineering
TransCore, LP —Germantown, MD
- $175,000 - $225,000 a year
- Computer science
- Computer Science
- Product management
- AD&D insurance
- Health insurance
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Senior Manager, Health & Safety Product Quality Assurance
Sodexo —North Bethesda, MD
- $86,275 - $133,870 a year
- Full-time
- 5 years
- Bachelor's degree
- Experience equivalent to degree accepted
- Paid holidays
- Health insurance
4d
Quality Assurance Manager / Configuration Management Specialist - Senior
iN2STEM Solutions Inc —Springfield, VA
- Full-time
- Computer Science
- SQL
- Bachelor's degree
Quick Apply
Senior Manager, Food Safety & Quality Assurance
HMSHost by Avolta —Bethesda, MD
- $99,900 - $121,100 a year
- ServSafe
- Office
- Bachelor's degree
- Health insurance
- Dental insurance
Senior Test Lead – Healthcare Payer Claims & GenAI
Cognizant —Rockville, MD
- $71,100 - $112,500 a year
- Full-time
- Remote
- Analysis skills
- Team management
- US work authorization
- Paid parental leave
- Employee stock purchase plan
FLEX Senior Manager - Quality Assurance Test Lead, Business Process Validation
Marriott International, Inc —Bethesda, MD
- $53.07 - $80.76 an hour
- Full-time
- Computer science
- Oracle
- Computer Science
- Commuter assistance
- Paid parental leave
Sr. Manager, Privia Quality Network Operations
Privia Health —Arlington, VA
- $90,000 - $110,000 a year
- Full-time
- HIPAA
- Master's degree
- Travel
- Health insurance
- Dental insurance
Quick Apply
12d
Sr. Manager, Product Management - Conversational AI Servicing Quality Assurance
Information Technology Senior Management Forum —McLean, VA
- $200,700 - $229,100 a year
- Email
- Computer Science
- Office
- Master's degree
- Health insurance
Senior Director, Research and Quality
American Nurses Association ANA —Silver Spring, MD
- $150,000 - $188,000 a year
- Full-time
- Nursing
- RN License
- 5 years
- Paid holidays
- Health insurance
Quick Apply
Senior Director, Research and Quality
American Nurses Association, Inc —Silver Spring, MD
- Full-time
- Nursing
- RN License
- 5 years
- Paid holidays
- Health insurance
Senior Offsite Commissioning Manager
Holder Construction —Herndon, VA
- Full-time
- Background check
- 7 years
- Engineering
- Health insurance
- Dental insurance
Quick Apply

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Senior Manager, Quality Systems & Compliance

MacroGenics -
Rockville, MD

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Job Details

$137,700 - $210,000 a year

Benefits

Paid parental leave
Employee stock purchase plan
Disability insurance
Health insurance
Dental insurance
Paid time off
Parental leave
Vision insurance
401(k) matching
Prescription drug insurance

Qualifications

Pharmaceutical regulatory compliance
Bachelor's degree
Pharmaceutical company experience
Biomedical regulatory compliance
FDA regulations
Pharmaceutical manufacturing facility experience

Full Job Description

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 350+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer. Our products and platforms have attracted multiple partnerships with leading pharmaceutical and biotechnology companies around the globe.

The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

Summary of Position

The Senior Manager, Quality Systems develops, maintains, and improves the Quality Management system, supporting Technical Operations, Quality, and Clinical Development/Operations. This individual plays an integral role in ensuring internal operations, processes and systems of the Quality department are flexible, functionable, and meet phase-appropriate compliance standards. This is a cross-functional role who serves as the primary liaison to internal customers for all Quality system related items associated with GMP, GCP, and GLP, with a strong focus on outsourced GMP operations.

Responsibilities and Job Duties

Responsible for electronic QMS deployment, administration, operation, and improvement. Communicates with other departments to resolve issues, identify and close gaps, and ensure ease of use of the QMS for personnel.
- Works with IT and external support services to configure the system over time as quality processes mature.
Develops flexible, clinical phase appropriate site quality systems and processes (training, document control, quality events), applying processes and standards in alignment with the organization’s strategy.
Authors and reviews QMS documentation such as SOPs, work instructions and other controlled document types.
Owns document management and control for electronic and paper-based systems.
Owns the company-wide training program and ensures appropriate company, role-specific and GxP training is provided to new and current staff.
Partners cross-functionally to drive quality operations inspection readiness, makes recommendations and leads continuous process improvement.
Provides input into quality event processes supporting external GMP operations, including deviations, CAPA, OOS/OOT, change control, SCARs and product complaints.
Supports and may host regulatory inspections and partner audits.
Perform other quality duties as assigned.

Qualifications

Education, Credentials & Experience

Bachelor’s degree in a science related field and a minimum of 7 (seven) years of experience working in a GxP environment
Minimum 5 (five) years experience working with biological products regulated under 21 CFR Part 600
Prior experience implementing and administering an eQMS for a biopharmaceutical company

Knowledge, Skills and Abilities

Knowledge of quality systems and USFDA cGMP regulations, industry practices, and international manufacturing regulations.
Expertise in quality systems for early phase development company
Proven experience as a quality and compliance subject matter expert
Strong cross functional communicator with excellent written and verbal communication skills
Self-motivator with excellent prioritization skills and resourcefulness in a fast-paced environment
Ability to build strong customer-focus relationships through responsiveness and delivery
Tactful with promoting quality standards and ability to drive quality improvements
Ability to operate effectively at both the management and operational level
Familiarity with biologics manufacturing operations and testing
Ability to accommodate occasional work outside of regular business hours for system administration or troubleshooting
Expertise in authoring and designing deviation, CAPA, OOS/OOT, SCAR, product complaint and change control processes
Travel up to 10% may be required for business support, training and development opportunities

Supervisory Responsibilities

May direct work of or delegate work to contractors

Preferred Qualifications

Experience maintaining clinical-stage quality assurance programs
Experience developing and/or managing quality systems for a biopharma company with an outsourcing model
Ability to perform GMP supplier audits
Experience ensuring compliance with GLPs and GCPs from a quality perspective

Additional Information

The annual rate of pay for this position ranges from $137,700 – $210,000. For non-exempt roles, and according to applicable regulations, there may be the possibility for overtime pay. This role is eligible for the Company’s discretionary bonus and discretionary equity incentives. Eligible employees may participate in the Company’s benefits programs, including medical / dental / vision / prescription coverage, employee wellness resources, 401(k) plan with employer match, access to an Employee Stock Purchase Plan, (ESPP), paid time off & paid parental leave benefits, and disability benefits.

The annual pay rate range is described in good faith, and the Company believes is the range of possible compensation for this role at the time of this posting depending on the candidate’s experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range, and this range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

Statement

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email [email protected] (mailto:[email protected]) or call (301) 354-3566 and/or 711 for TTD/TTY service.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.

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Refine Your Search

senior manager quality jobs in ashburn, va

Senior Manager, Quality Systems & Compliance

Senior Program Quality Manager

Senior Technical Program Manager, Infrastructure Reliability and Quality (IRQ)

National Tax Senior Manager - Quality Assurance and Risk Management

Quality Assurance Manager - Senior

Senior Manager Quality

Senior Director, Quality

Sr. Reliability Technical Program Manager, Infrastructure Reliability & Quality

Sr. Reliability Product Manager-Tech, Infrastructure Reliability & Quality

Sr Director, Quality Engineering

Senior Manager, Health & Safety Product Quality Assurance

Quality Assurance Manager / Configuration Management Specialist - Senior

Senior Manager, Food Safety & Quality Assurance

Senior Test Lead – Healthcare Payer Claims & GenAI

FLEX Senior Manager - Quality Assurance Test Lead, Business Process Validation

Sr. Manager, Privia Quality Network Operations

Sr. Manager, Product Management - Conversational AI Servicing Quality Assurance

Senior Director, Research and Quality

Senior Director, Research and Quality

Senior Offsite Commissioning Manager

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