Top 24 Director of quality assurance Jobs in West Point Pa

Sr. Director, Quality Assurance for Quality Control
Vaxcyte —Philadelphia, PA
- $229,000 - $268,000 a year
- Remote
- 11+ years
- Bachelor's degree
- Senior level
Director of Quality Management - PCAM
Penn Medicine —Philadelphia, PA
- Full-time
- Computer science
- Nursing
- Computer Science
- Tuition reimbursement
Quick Apply
Quality/Performance Director
Amentum —Philadelphia, PA
- $150,000 - $180,000 a year
- Full-time
- Background check
- Bachelor's degree
- Organizational skills
- Employee stock purchase plan
- Paid holidays
Associate Director, Quality (Validation and Data Integrity)
Larimar Therapeutics —Bala-Cynwyd, PA
- Full-time
- Office
- 8 years
- Bachelor's degree
- 401(k)
- Paid time off
Quick Apply
Director of Quality Evolution
Wesley Enhanced Living —Warminster, PA
- Full-time
- Master's degree
- Bachelor's degree
- Senior level
- Dental insurance
- 401(k) matching
8d
Associate Director, Quality Assurance-Hospice
BAYADA Home Health Care —Pennsauken, NJ
- $110,000 - $114,000 a year
- Remote
- Microsoft Word
- 7 years
- RN License
Quick Apply
Director, Quality
Catalent —Philadelphia, PA
- Email
- Bachelor of Science
- Bachelor's degree
- Organizational skills
- Health insurance
- Dental insurance
Director, Quality
Globus Medical —Audubon, PA
- Full-time
- 5 years
- Computer literacy
- Bachelor of Science
Director, Quality (External Manufacturing)
Paratek Pharmaceuticals —King of Prussia, PA
- Hybrid work
- 11+ years
- Bachelor's degree
- Travel
1d
Director of Quality and W Insider
Marriott International, Inc —Philadelphia, PA
- $82,000 - $103,000 a year
- Full-time
- Hotel
- Bachelor's degree
- Business Administration
1d
Director, Assurance and Supplier Quality
mSupply —Glen Mills, PA
- Overtime
- Engineering
- ERP systems
- Office
- Health savings account
- Paid holidays
Quick Apply
Director, Clinical Quality Assurance
Jazz Pharmaceuticals —Philadelphia, PA
- $184,000 - $276,000 a year
- Remote
- Writing skills
- 11+ years
- Master's degree
- Health insurance
- Dental insurance
14d
Director of Quality, Compliance & Clinical Education | Home Health Required
KeystoneCare —Wyndmoor, PA
- $90,000 - $100,000 a year
- Full-time
- CPR Certification
- Nursing
- RN License
- Paid holidays
- Health insurance
Quick Apply
Director, Quality Engineering
Starr Companies —Philadelphia, PA
- Full-time
- Computer Science
- Master's degree
- Mentoring
Quality R&D Operations Drug Substance Director
GlaxoSmithKline —King of Prussia, PA
- Full-time
- 5 years
- Bachelor's degree
- Doctor of Philosophy
Dir, Quality Assurance
West Pharmaceutical Services —Exton, PA
- Hybrid work
- Background check
- Senior level
- Leadership
- Relocation assistance
3d
Sr. Director, Sterility Assurance – Global Quality Technical Operations
PCI Pharma Services —Philadelphia, PA
- Weekends as needed
- Management
- 5 years
- Computer literacy
Director, Manufacturing Quality, GIS (Japan Based)
Olympus —Center Valley, PA
- $134,666 - $188,532 a year
- Full-time
- Remote
- Analysis skills
- Bachelor's degree
- Travel
- Paid parental leave
- Paid holidays
Director, Validation
Cabaletta Bio —Philadelphia, PA
- Computer Science
- Engineering
- 11+ years
- Health insurance
- Paid time off
Sr. Director, eCompliance – Global Quality Technical Operations
PCI Pharma Services —Philadelphia, PA
- Weekends as needed
- Computer Science
- 5 years
- Computer literacy

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Sr. Director, Quality Assurance for Quality Control

Vaxcyte -
Philadelphia, PA

Apply Now

Job Details

$229,000 - $268,000 a year

Qualifications

Drug regulation
GMP
Global team management
Team development
ICH guidelines
Quality risk management
Pharmaceutical analysis
Quality assurance experience within pharmaceutical industry
Collaboration with manufacturing teams
Managing projects
Verification of laboratory test methods
Quality control experience within pharmaceutical industry
Managing product quality assurance teams
Test validation method
Cross-functional team management
Cross-functional communication

Full Job Description

Join our Mission to Protect Humankind!

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.

WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:

RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.

AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.

LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.

MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

Summary:

This role is pivotal in ensuring compliance with global regulatory guidelines and supporting our pipeline of high-fidelity vaccines. Vaxcyte is looking for an energetic and talented individual to join our Quality Assurance team as a Senior Director. This role carries dual accountability: providing direct QA support to the analytical operations based in Switzerland, while also managing the San Carlos-based QA team responsible for oversight of smaller-scale analytical activities. The Senior Director will be expected to operate effectively across both sites, navigating the distinct regulatory environments and operational cadences of each. The primary responsibility will be the QA oversight of QC activities associated with Vaxcyte's PCV Polysaccharides and Drug Substances. The Senior Director will work closely with internal teams (Process Development, MSAT, Quality Control, Regulatory, and Stability) and external partners (CDMOs and CTLs) to maintain the compliance of the analytical program.

Essential Functions:

Lead quality oversight activities related to method validation, release and in-process testing for Drug Substance and Polysaccharide
Serve as the primary liaison within Vaxcyte QA and with outside collaborators, building partnerships that support analytical needs for relevant programs.
Represent QA at internal and external cross functional team meetings.
Lead review and approval of internal and external GMP documentation for compliance, including specifications, Certificates of Analysis, validation reports, deviations, change controls, risk assessments, and CAPAs as they relate to polysaccharides and drug substance; apply technical and compliance expertise to critically evaluate reference standards, test methods, protocols, and raw data packages from CMOs and contract testing laboratories.
Partner with QC, vendor management, and contract labs to set key performance indicators for monitoring vendor effectiveness.
Drive resolution of quality performance issues with contract manufacturers and testing organizations
Review Quality Agreements and regulatory documentation as required.
Lead quality investigations of testing deviations and OOS.
Contribute to regulatory filings, respond to questions from health authorities, and ensure quality of documentation used in support of regulatory submissions.
Take part in audit preparations and help ensure ongoing readiness.
Develop, review, and update GMP-related internal policies and procedures as necessary.
Champion a culture of quality excellence and continuous improvement by proactively identifying systemic gaps, driving implementation of sustainable solutions, and establishing performance standards that elevate GMP compliance across internal teams and external partners.

Requirements:

Bachelor's degree in Biochemistry, Chemistry, or a related field with 15+ years of relevant industry experience. Other combinations of education and/or experience may be considered.

Thorough knowledge of applicable FDA, EU, and ICH regulatory guidelines and pharmacopeia for method qualification and validation in biologics and vaccines, along with proven expertise in applying these regulations to develop practical solutions and phase-appropriate analytical strategies.
Experience working with biochemistry, immunoassay, or microbiological assay techniques in a Quality Control environment.
Excellent organizational and project management skills, with the ability to handle multiple projects under tight timelines.
Excellent written and verbal communication skills, including the ability to work effectively in cross-functional teams.
Previous experience in validation and transfer of analytical assays.
Demonstrated ability to build and develop high-performing QA teams and influencing cross-functional and executive stakeholders in a fast-paced commercial-stage biotech company.
Knowledge and experience in Risk Management principles.
Knowledge in both clinical and commercial product desired.
Ability to integrate and interpret interdisciplinary project information; with at least a high-level understanding of the drug/vaccine development process.
Ability to work globally with CMOs in different countries and continents.
Experience managing geographically distributed QA teams across multiple sites or countries, with the ability to build cohesive quality culture and consistent GMP standards across locations.
Experience in BLA submission and commercial launch is highly desirable

Reports to: Executive Director, Quality Assurance

Location: Raleigh, NC

Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): Remote

Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.

Salary Range: $229,000 – $268,000 (North Carolina)

Equal Opportunity

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Recruitment Fraud Notice

Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent Vaxcyte in recruitment activities. Vaxcyte has an established recruitment process for all positions prior to issuing an offer for employment and we will never extend unsolicited employment offers or ask candidates to provide financial or sensitive personal information as part of the application process. All legitimate communication from Vaxcyte will come from an official @vaxcyte.com email address. Qualified and interested candidates should apply to current openings at vaxcyte.com/careers.

Apply Now

Refine Your Search

director of quality assurance jobs in west point pa

Sr. Director, Quality Assurance for Quality Control

Director of Quality Management - PCAM

Quality/Performance Director

Associate Director, Quality (Validation and Data Integrity)

Director of Quality Evolution

Associate Director, Quality Assurance-Hospice

Director, Quality

Director, Quality

Director, Quality (External Manufacturing)

Director of Quality and W Insider

Director, Assurance and Supplier Quality

Director, Clinical Quality Assurance

Director of Quality, Compliance & Clinical Education | Home Health Required

Director, Quality Engineering

Quality R&D Operations Drug Substance Director

Dir, Quality Assurance

Sr. Director, Sterility Assurance – Global Quality Technical Operations

Director, Manufacturing Quality, GIS (Japan Based)

Director, Validation

Sr. Director, eCompliance – Global Quality Technical Operations

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