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Director, Commercial Quality Assurance

3 months ago

Des Plaines, Illinois, United States Capstone Development Services Co, LLC Full time

Company

Capstone, a fast-growing, private equity-owned pharmaceutical company; develops complex generic products, internally and for commercial partners, located in Rosemont, IL

Overview

Responsible for ensuring the quality, safety and compliance of our commercial pharmaceutical products throughout their lifecycle, focused on oversight of QA with contract manufacturing organizations (CMOs).

Key Responsibilities

  1. Quality Assurance Oversight provide strategic direction and oversight of all quality assurance activities related to commercial pharmaceutical products including batch release, deviation management, change control and CAPA (Corrective and Preventive Action) implementation. Establish and maintain robust quality systems and processes to ensure compliance with regulatory requirements, quality standards, and company policies.
  2. Supplier Quality Management - collaborate with CMOs to establish and maintain strong quality partnerships, ensuring they adhere to established quality agreements, standards, and protocols. Assist with supplier audits and assessments to evaluate CMO compliance with quality requirements and identify areas for improvement.
  3. Quality Risk Management implement risk-based approaches to quality assurance, including risk assessment, mitigation strategies, and continuous improvement initiatives to enhance product quality and plant safety. Lead risk management activities including the identification, assessment, and mitigation of quality risks throughout the product lifecycle.
  4. Regulatory Compliance: stay abreast of changes in regulatory requirements related to commercial pharmaceutical product quality assurance and ensure compliance with applicable regulations, including FDA, EMA, and other regulatory agencies. Collaborate with regulatory affairs to prepare and submit regulatory filings and responses to regulatory inquiries as needed.
  5. Cross-Functional Collaboration: Collaborate closely with cross-functional teams, including manufacturing, regulatory affairs, pharmacovigilance, and supply chain, to ensure alignment of quality assurance activities with business objectives and regulatory requirements. Drive a culture of quality and continuous improvement across the organization through effective communication, training, and collaboration.

Qualifications

  • Bachelors degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or related field; advanced degree (e.g., PharmD, MBA) preferred.
  • Minimum of 10 years of experience in quality assurance roles in the pharmaceutical industry, with a focus on commercial operations and manufacturing.
  • Strong knowledge of pharmaceutical quality systems, cGMP regulations, and industry best practices.
  • Experience managing quality assurance activities for commercial pharmaceutical products and/or portfolios, including batch release, deviation management, and CAPA processes.
  • Proven leadership skills with the ability to effectively lead and motivate cross-functional teams.
  • Excellent communication, negotiation, and interpersonal skills.
  • Ability to thrive in a fast-paced, dynamic environment and adapt to changing priorities and deadlines.

Compensation

Competitive health benefits, 401k plan, salary, annual incentive and long-term incentive opportunity.

Send resumes to:

NOTE: Local candidates preferred; 3-day office requirement