Top 104 Quality assurance manager Jobs in Langhorne, Pa

Quality Systems Manager
Myonex —Horsham, PA
- From $100,000 a year
- Full-time
- Office
- Bachelor's degree
- Mentoring
Quality Manager
M&C Specialties —Southampton, PA
- $90,000 - $112,000 a year
- Full-time
- Supervising experience
- Bachelor's degree
- Mentoring
- Paid holidays
- Disability insurance
7d
Area Manager - Quality Assurance/Systems
Walmart —Westampton, NJ
- $72,050 - $108,000 a year
- High school
- Writing skills
- Mid-level
- Paid jury duty
- Disability insurance
12d
QA Lead
GCH Technologies —Philadelphia, PA
- $130,000 - $165,000 a year
- Spanish
- 5 years
- Pass drug screening
- Paid parental leave
- Health savings account
Quality Control Manager
Frankford Candy, LLC —Philadelphia, PA
- $105,000 - $110,000 a year
- Full-time
- Microsoft Word
- 7 years
- Supervising experience
Quick Apply
Quality and Records Manager
HDR —Pennington, NJ
- $89,114 - $127,305 a year
- Full-time
- 6 years
- Management
- Office
- Paid holidays
- Disability insurance
Quality Assurance Supervisor
Catalent —Philadelphia, PA
- Email
- 5 years
- Bachelor of Science
- Microsoft Office
- Paid holidays
- Health insurance
Manager Quality Assurance Operations
Catalent —Princeton, NJ
- $130,000 - $160,000 a year
- Email
- Engineering
- English
- 3 years
- Paid holidays
- Health insurance
QA Manager/Associate Director – Quality Assurance (Job Code: QA)
Primera Analytical Solutions —Princeton, NJ
- 5 years
- Bachelor of Science
- Bachelor's degree
8d
Quality Assurance Manager
Focus Laboratories —Cherry Hill, NJ
- $110,000 - $120,000 a year
- Full-time
- Management
- Bachelor's degree
- Senior level
Quick Apply
13d
Quality Control Manager
ACTION MANUFACTURING COMPANY —Bristol, PA
- Full-time
- 6 years
- Computer Science
- Engineering
- Health savings account
- Health insurance
Quick Apply
Technical Service Manager
The Wenger Group —Souderton, PA
- Full-time
- Microsoft Excel
- Customer service
- Ability to walk for extended periods
- Health savings account
- AD&D insurance
Quick Apply
Quality Manager
GWYNEDD MANUFACTURING INC —North Wales, PA
- $95,000 - $115,000 a year
- 8 hour shift
- Engineering
- Master's degree
- Analysis skills
Quick Apply
Director, Data Quality and Process, External Data Clinical Data Management
Genmab —Princeton, NJ
- $189,200 - $283,800 a year
- Online Application
- 5 years
- Bachelor's degree
- Doctor of Philosophy
- Commuter assistance
- Paid parental leave
Manager, Quality Engineering
L3Harris Technologies —Camden, NJ
- $128,500 - $185,000 a year
- Full-time
- 7 years
- Analysis skills
- Bachelor's degree
- Paid holidays
- Disability insurance
Senior Quality Assurance Automation Manager
United States Cold Storage Inc —Camden, NJ
- $160,000 - $190,000 a year
- Hybrid work
- Azure
- Computer Science
- 5 years
- Commuter assistance
- AD&D insurance
Quick Apply
Quality Control Supervisor
Katzman Distribution Burlington —Burlington, NJ
- $66,000 - $73,000 a year
- Full-time
- Mid-level
- Quality control
- Mentoring
- Health insurance
- Dental insurance
Quick Apply
1d
K-12 Construction Manager / NICET Inspector
NEW ROAD Construction Management —Cherry Hill, NJ
- $80,000 - $100,000 a year
- Full-time
- Spanish
- Construction site
- Computer literacy
- Health savings account
- Paid holidays
Quick Apply
Certified Bridge Inspector - CBSI Team Lead
Everforth, Cybercoders —Newtown, PA
- $70,000 - $80,000 a year
- Full-time
- Mid-level
- Analysis skills
- Driver's License
Quick Apply
5d
Manager of Food, Safety and Risk
Insomnia Cookies —Philadelphia, PA
- $90,000 - $100,000 a year
- Full-time
- Hybrid work
- Hospitality
- 5 years
- Analysis skills
- Health insurance
- Dental insurance
Quick Apply
8d

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Quality Systems Manager

Myonex
Horsham, PA

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Job Details

Full-time
From $100,000 a year

Qualifications

Drug regulation
Quality control audit
ICH guidelines
Quality assurance experience within pharmaceutical industry
FDA regulations

Full Job Description

Vacancy No

VN324

Location Country

United States

Location Region

Pennsylvania

Location City

Horsham

Employment Type

Full Time

Salary Range

Starting at $100,000 based on experience

Job Details

Primary Role:

The Quality Systems Manager at Myonex is responsible for overseeing Myonex’s Pharmaceutical Quality System to ensure compliance with GMDP requirements. This role leads quality systems, audit programs, vendor qualification, and training, while managing the Quality Systems team and collaborating cross-functionally with Production Quality and Operational teams.

This role is hybrid (3 days a week onsite) at our Headquarters in Horsham, PA with working days of Monday - Friday at 8AM - 4:30PM.

Duties:

Maintain and continuously improve the Pharmaceutical Quality System, including change control, deviations, CAPA, complaints, recalls, document control, training, risk management, vendor qualification, equipment/facility maintenance, calibration, and quality management review.
Monitor quality system activities (e.g., change controls, deviations, investigations, CAPAs) to ensure timely progression, effective resolution, and proper closure.
Lead investigations related to deviations, OOS results, and complaints, ensuring appropriate root cause analysis and corrective/preventive actions.
Author, review, and approve Standard Operating Procedures (SOPs), technical agreements, and other controlled documents.
Archive quality documents accurately within electronic and physical document management systems.
Manage internal and external audit programs, including self-inspections, supplier audits, and customer audits; host audits and support regulatory inspections as needed.
Participate in supplier qualification and ongoing monitoring, including risk assessments, approvals, and periodic re-evaluations.
Coordinate and maintain training programs, including training needs analysis, development of training plans, and ensuring completion of GMDP and role-specific training.
Drive quality culture and ensure compliance with cGMP, FDA, ICH, and other applicable regulatory requirements.
Lead risk management activities, including identification, evaluation, and mitigation of risks.
Organize and lead Quality Management Review meetings, including development and presentation of quality metrics.
Maintain and manage technical agreements with suppliers and service providers.
Manage, mentor, and develop Quality Systems team, including onboarding, training, performance management, and workload planning.
Escalate significant quality, compliance, or operational risks to the Associate Director, Quality, or senior management, as appropriate.
Perform additional GMDP-related duties as assigned by the Associate Director, Quality.
Embody the Myonex Core Values: Be a Great Team Player; Be Client Focused; Learn & Grow; Find a Way

Education & Experience:

Bachelor’s degree in science or related field with 3 to 6 years of related experience in pharmaceutical quality assurance or a combination of FDA regulated environment in quality/regulatory fields.
7 or more years of relevant experience in an FDA regulated environment in lieu of education is acceptable.
1-2 years’ experience in auditing.
Working knowledge of cGMP principles with respect to appropriate regulatory requirements (FDA, ICH guidelines).

Skills & Qualifications:

Strong decision-making, analytical, and problem-solving skills with the ability to evaluate complex situations and drive effective outcomes.
Demonstrated ability to plan, prioritize, and manage multiple projects and responsibilities simultaneously while meeting deadlines and adapting to changing priorities.
Excellent organizational skills with a high level of accuracy and attention to detail.
Solid understanding of GMP, GDP, and other applicable regulatory requirements; general knowledge of EU regulatory requirements preferred.
Strong written and verbal communication skills, including report writing and the creation and revision of technical and quality documentation.
Effective interpersonal skills with the ability to coach, guide, and influence stakeholders at all levels of the organization.
Results-oriented, self-motivated, and driven, with the ability to work independently with minimal supervision.
Ability to identify procedural gaps and proactively drive continuous quality and compliance improvements.
Proficient computer skills, including Microsoft Office applications, email systems, and inventory management software.

Myonex is committed to ensuring equal opportunity in all aspects of employment. We do not discriminate against anyone on the basis of race, religion/creed, color, gender identity, sexual orientation, marital status, pregnancy, national origin, ancestry, military status, disability or perceived disability, use of a guide or disability support animal, or membership in any other protected class as defined by applicable laws and regulations. If an employee or applicant feels they have not received equal or fair treatment, we encourage them to contact Human Resources.

Apply Now

Refine Your Search

quality assurance manager jobs in langhorne, pa

Quality Systems Manager

Quality Manager

Area Manager - Quality Assurance/Systems

QA Lead

Quality Control Manager

Quality and Records Manager

Quality Assurance Supervisor

Manager Quality Assurance Operations

QA Manager/Associate Director – Quality Assurance (Job Code: QA)

Quality Assurance Manager

Quality Control Manager

Technical Service Manager

Quality Manager

Director, Data Quality and Process, External Data Clinical Data Management

Manager, Quality Engineering

Senior Quality Assurance Automation Manager

Quality Control Supervisor

K-12 Construction Manager / NICET Inspector

Certified Bridge Inspector - CBSI Team Lead

Manager of Food, Safety and Risk

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