Top 12 Director of quality Jobs in Limerick Pa

Director, Quality (External Manufacturing)
Paratek Pharmaceuticals —King of Prussia, PA
- Hybrid work
- 11+ years
- Bachelor's degree
- Travel
4d
Director, Quality
Globus Medical —Audubon, PA
- Full-time
- 5 years
- Computer literacy
- Bachelor of Science
Director, Quality and Food Safety
The Boston Beer Company —Breinigsville, PA
- $158,000 - $284,000 a year
- Full-time
- Hybrid work
- Management
- 11+ years
- Office
- Wellness program
- Employee stock purchase plan
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
11d
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
7d
Director, Assurance and Supplier Quality
mSupply —Glen Mills, PA
- Overtime
- Engineering
- ERP systems
- Office
- Health savings account
- Paid holidays
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Director of Quality, Compliance & Clinical Education | Home Health Required
KeystoneCare —Media, PA
- $90,000 - $100,000 a year
- Full-time
- CPR Certification
- Nursing
- RN License
- Paid holidays
- Health insurance
Quick Apply
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
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 – Financial Due Diligence (Quality of Earnings)
Hollywell Partners LLC —United States
- CPA
- 5 years
- Finance
9d

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Director, Quality (External Manufacturing)

Paratek Pharmaceuticals -
King of Prussia, PA

Apply Now

Job Details

4 days ago

Qualifications

Regulatory inspections
Communication with suppliers
Microbiology testing
Drug regulation
Quality control audit
Supplier audits
Bachelor's degree
Pharmaceutical company experience
Pharmaceutical analysis
Quality assurance experience within pharmaceutical industry
Internal compliance assessments
Regulatory/legal compliance standards in production
Regulatory submissions
Verification of laboratory test methods
Quality control experience within pharmaceutical industry
Microbiological analysis
Productivity software
Test validation method
Audit support
Pharmaceutical manufacturing facility experience

Full Job Description

Position Title: Director, Quality , External Manufacturing

Department: Technical Operations, Quality, and Supply Chain

Reports To (title): Senior Director, Quality, External Manufacturing

Location: King of Prussia, PA (hybrid work environment)

Exempt Non-Exempt

Summary of Position:

The Director of External Manufacturing Quality is responsible for leading and overseeing quality activities across contract manufacturing organizations (CMOs), contract laboratories, suppliers, and external partners supporting the company's clinical and commercial pharmaceutical and medical device portfolio with emphasis on Drug Substance. This role ensures compliance with global regulatory requirements, maintains product quality, and drives continuous improvement where applicable. The Director of External Manufacturing Quality will provide strategic leadership for external quality systems supporting commercial pharmaceutical products, medical devices, and future pipeline products with emphasis on Drug Substance. The position partners closely with Technical Operations, Quality Management System, Supply Chain, Regulatory Affairs, Development, and Commercial to ensure uninterrupted product supply and regulatory compliance. The role is also responsible for writing/reviewing/approving SOPs, QTAs, APRs, Supplier Qualification forms, Health Authority Inspections, Product Complaints, etc.

Position Responsibilities:

Drive collaboration within internal and external cross-functional groups to achieve objectives and communicate company expectations as necessary to improve relationship performance against agreed-upon metrics and business goals.
Serve as the primary quality representative for strategic supplier and CMO relationships.
Work with Contract Manufacturing Organizations (CMOs) to develop a quality culture that is aligned with Paratek expectations.
Represent Quality at key internal and external
Review and approve investigations, deviations, CAPAs, change controls, and product impact assessments originating from external partners.
Perform thorough batch record review and release, in an efficient and timely manner; assure non-conformances are properly investigated and explained, and calculations are correct. Review batch documentation and check against registered specifications prior to market release or advising rejection of batch. Ensure Paratek release documentation for each batch is accurate and filed according to
Provide leadership for key QMS processes such as change control, investigations, deviations and complaints and support execution of the QMS related to document development, review and approval as applicable to ensure compliance is achieved and maintained (i.e. SOPs, APR, complaints, deviations, investigations).
Act as QA SME for CMC related issues and regulatory filings, with emphasis on Drug Substance.
Ensure that Quality Technical Agreements (QTAs) with Paratek suppliers are established, maintained, implemented, and
Audit Service Providers and manage all follow-up activities. Perform and participate in internal and external cGxP audits as required. This includes PAI readiness.
Participate in internal and external cGxP Health Authority inspections, as
Conduct review of completed GxP audits to identify systemic trends requiring
Directly interact with GxP Service Providers to drive remediation as
Participate in Product Recalls/Withdraws, as
Act as Senior QA leadership and review and approve Major/Critical
Manage and develop direct report and/or mentor junior team members.
Assess and support GMP compliance for analytical topics to maintain compliance with the principle of GMP as required by regulatory filings as well regional or national laws and guidelines.

Candidate Requirements:

Emulates Paratek's core values - Passionate, Resourceful, Collaborative, Purposeful
Bachelor's degree in chemistry, biology, or related discipline
Practical experience for at least 15 years in the pharmaceutical industry specifically in the manufacturing/technical/QA functions with at least 12 or more years of direct QA experience required.
Strong working knowledge of US cGMPs for clinical and commercial pharmaceutical and medical device portfolio with emphasis on Drug Substance.
Strong understanding of analytical method validation, pharmaceutical drug substance/drug product analytical technique and microbiological testing
Experience working with Service Providers and with managing QTAs, conducting site audits,
Strong current knowledge of local and international regulatory and legislative requirements to ensure that technical support on all quality related matters is provided to the country.
Familiarity with Field Alert Reporting and participation is Health Authority inspections is also required.
Logical problem solver who can remediate issues in a timely
Excellent organization, written/verbal communication and attention to
Good self-starter.

Additional Information:

Technology needs: Microsoft Office, Veeva
Travel requirements (%): 30% as needed both domestic and international

Apply Now

Refine Your Search

director of quality jobs in limerick pa

Director, Quality (External Manufacturing)

Director, Quality

Director, Quality and Food Safety

Director of Quality Evolution

Quality R&D Operations Drug Substance Director

Dir, Quality Assurance

Director, Assurance and Supplier Quality

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

Director, Manufacturing Quality, GIS (Japan Based)

Associate Director, Quality (Validation and Data Integrity)

Director – Financial Due Diligence (Quality of Earnings)

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