Description

The Quality Contracts Manager will collaborate directly with Quality Representatives for each Pharma Services Group (PSG) entity/site. This role involves reviewing, drafting, negotiating, and coordinating client Quality (Technical) Agreements to adhere to PSG Quality policies and GMP requirements. The Quality Contracts Manager will develop negotiation strategies and coordinate with multiple resources to support business objectives and achieve profitable growth.

Company Culture and Environment

The work environment emphasizes collaboration and teamwork, with a focus on achieving high-quality standards and compliance in pharmaceutical services.

Career Growth and Development Opportunities

This position provides opportunities to enhance negotiation skills and gain experience in Quality Assurance and Regulatory Compliance, paving the way for career advancement within the pharmaceutical industry.

Detailed Benefits and Perks

While specific benefits are not outlined, the role offers the opportunity to work in a dynamic and impactful industry, contributing to the quality of pharmaceutical products.

Compensation and Benefits

• Competitive contract-based compensation
• 100% remote work flexibility
• Opportunities for professional development

Why you should apply for this position today

Joining as a Quality Contracts Manager offers a unique chance to impact the pharmaceutical industry while working in a remote, flexible environment. You will play an essential role in ensuring compliance with quality standards that affect patient safety and product efficacy.

Skills

• Effective negotiation skills
• Excellent technical writing and communication skills
• Strong organizational and project management abilities
• Familiarity with computerized systems for Quality Agreement management
• Proficiency in MS Office products

Responsibilities

• Review, draft, negotiate, and coordinate Quality (Technical) Agreements
• Ensure completion of required reviews and approvals from Quality personnel
• Integrate QP tasks into Quality Agreements
• Conduct risk assessments on QA/GMP provisions and develop recommendations
• Track and report on Quality Agreement statuses
• Assist in designing and implementing policies for timely execution of agreements

Qualifications

• At least 6 years of Quality Assurance and/or Regulatory Compliance experience
• Knowledge of EU GMP regulations and guidelines
• Experience with US FDA GMP regulations
• Strong interpersonal and analytical skills
• Excellent attention to detail and communication skills

Education Requirements

• Minimum of a Bachelor’s degree in a scientific field (preferably Chemistry or Biology)

Education Requirements Credential Category

• Bachelor’s degree in a scientific field

Experience Requirements

• At least 6 years of relevant experience in Quality Assurance and Regulatory Compliance
• Experience in Clinical Trial Material (CTM) manufacturing and regulatory requirements
• Experience with negotiation and management of Quality Agreements

Why work in South San Francisco, CA

South San Francisco is at the heart of the biotechnology and pharmaceutical industry, offering a vibrant community filled with innovation and opportunities for professional growth. The city’s proximity to leading companies provides a rich landscape for networking and career advancement.