Sr. Project Manager, Quality Assurance; QA

Job Responsibilities

• Maintain and revise QA related procedures, as needed.
• Maintain cGMP training systems and perform on‑site team member training in Quality related matters.
• Ensure GxP support and oversight, as applicable, for relevant site functions and activities.
• Support QA team members with senior QA level knowledge, experience, guidance, coaching and mentoring, as required.
• Perform QA batch record review and disposition of manufactured early‑phase clinical product batches.
• Provide final QA approval of investigations and disposition of any impacted product batches.
• Evaluate deviations and propose batch rejections, if applicable.
• Perform QA review and approval of the following, as needed:
  • Environmental monitoring data in GMP clean rooms and adjacent areas, as well as Clean Utility monitoring data.
  • Investigation of non‑conforming product.
  • Investigation of out‑of‑specification (OOS) results.
• Manage and approve change controls, as required for facilities, equipment, systems and processes, Corrective Action/Preventive Action (CAPAs), and deviations.
• Provide direct QA resources to support process development teams.
• Perform or support internal audits/self‑inspections.
• Perform or support qualification of suppliers.
• Perform QA review and approval of the following:
  • Facility and equipment qualification protocols and final reports.
  • Provide or support QA review and approval of analytical methods, standards and specifications.
• Support, coordinate and/or host customer audits as required. Support audit response creation and execution, as needed.
• Effectively communicate with client QA personnel as project support.
• Provide QA support for development of validation strategies and validation plans, including Computer System Compliance (CSC) efforts.
• Establish and manage QA tracking and trending of program measures and the preparation of periodic reports for management review. Maintain appropriate KPIs to monitor performance and improvement.
• Propose and develop continuous quality initiatives to improve efficiency and/or improve the level of control and compliance.
• Support and promote the company safety program by obtaining and using all personal protective equipment as appropriate, observing all safety procedures and practices, and assuring that other employees similarly use personal protective equipment. Perform other duties as may be required by management.

• Minimum B.S. degree in chemistry, biology, microbiology, biomedical or chemical engineering or equivalent education.
• Preferably ten (10) to twelve (12) years’ experience in Quality Assurance/Quality Control in the biopharmaceutical or pharmaceutical manufacturing industry (early‑phase and/or commercial), at least 2 years in a leadership position.
• Experience with hosting foreign and domestic regulatory inspections (US‑FDA, EU authorities, Health Canada).
• Knowledge of cGMP requirements and experience in their application and interpretation for finished dosage forms.
• Strong organizational skills.
• Advanced problem‑solving skills.
• Advanced written and verbal communication skills.
• Excellent interpersonal skills.
• Strong leadership skills.
• Knowledge of Office software systems including Word, Excel and Access.
• Proven experience in pharmaceutical regulatory requirements.
• Ability to advise others in the majority of situations.
• Results orientation.
• Redesign practices and processes for breakthrough results.
• Significantly improves organization’s practices, processes and quality.
• Senior fluency in quality risk management principles and risk tool usage, including strong ability to mentor others in Quality Risk Principles and workflows.
• Role orientation/strategic orientation.
• Leads improvement areas, redesigns processes and manages QA activities with best practices.
• Supports definition of standards for quality systems and compliance.
• Supports Director, Quality with setting the annual QA priorities and defining specific plans, with team involvement.
• Facilitates cross‑functional team activities.
• Leads collaboration within organization.
• Sets model of collaborative culture and leadership.
• Understands and commits to demonstrating high emotional intelligence (self‑awareness, self‑regulation, empathy, social…