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Quality Assurance Manager - Job Opportunity at Glenmark Pharmaceuticals Inc.

Allentown, USA
Full-time
Senior
Posted: April 20, 2025
On-site
USD 110,000 - 140,000 annually based on location and experience requirements

Benefits

Competitive 401(k) with company match demonstrating strong retirement focus
Comprehensive health coverage with no premium sharing
Wellness-oriented benefits including on-site gym access
Work-life balance support through generous PTO
Extended insurance package including pet and critical illness coverage
Employee development through referral program and EAP

Key Responsibilities

Strategic oversight of Quality Management System (QMS) including deviations, CAPA, and change control processes
Leadership of compliance initiatives ensuring adherence to cGMP and agency regulations
Management of CMO/Vendor relationships including quality agreements and audits
Controlled substance handling oversight with DEA compliance responsibility
Cross-functional project leadership for quality/compliance initiatives

Requirements

Education

Bachelor's degree (or equivalent) in Science

Experience

5-7 years of experience in pharmaceuticals industry, preferably in Quality Department

Required Skills

Well-versed with current FDA and DEA regulations Proficient with MS Office SAP or other ERP system experience Physical ability to lift up to 20 pounds
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Sauge AI Market Intelligence

Industry Trends

Pharmaceutical quality assurance is experiencing increased scrutiny due to supply chain complexities and regulatory evolution Integration of digital QMS systems is becoming standard, driving demand for technical expertise alongside traditional quality knowledge Growing focus on vendor quality management as pharmaceutical manufacturing becomes more distributed

Role Significance

Typically leads a team of 3-7 quality professionals while coordinating with multiple departmental stakeholders
Senior management position with direct impact on product quality and regulatory compliance, typically reporting to Quality Director or VP

Key Projects

Quality Management System implementation and optimization Regulatory audit preparation and management Vendor quality program development Controlled substance compliance program oversight

Success Factors

Strong regulatory knowledge spanning FDA, DEA, and cGMP requirements Excellent project management capabilities across multiple stakeholders Strategic thinking in quality system development Effective communication skills for cross-functional leadership

Market Demand

High demand role with steady growth projected due to expanding pharmaceutical manufacturing and increasing regulatory requirements

Important Skills

Critical Skills

Regulatory compliance expertise spanning multiple agencies Quality system management and development Vendor quality oversight and audit capabilities

Beneficial Skills

Project management certification Risk management expertise Digital quality system experience

Unique Aspects

Combination of traditional QA responsibilities with controlled substance oversight
Strong focus on CMO management indicating strategic outsourcing model
Emphasis on both systems and hands-on quality management

Career Growth

2-4 years in role typical before advancement, depending on organizational structure and performance

Potential Next Roles

Quality Director Head of Quality VP of Quality Global Quality Leadership positions

Company Overview

Glenmark Pharmaceuticals Inc.

Established pharmaceutical company with strong generic drug portfolio and growing innovation focus

Mid-sized player in the US generics market with global presence and increasing specialty drug development
Strategic location in Pennsylvania pharmaceutical hub with significant manufacturing partnerships
Professional corporate environment with emphasis on compliance and quality excellence
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