Pharmaceutical Quality Project Manager

Location: College Station, TX
Department: Azzur Austin, LLC

Job Description

We at Azzur Group are looking for an experienced Pharmaceutical Quality/Regulatory Project Manager to join our Azzur Consulting: Austin team. The Pharmaceutical Quality/Regulatory Project
Manager will have a focus on Pre-Approval Inspection Readiness and be responsible for the planning & delivery of projects from scoping of work, defining schedule, planning resources, and then executing the
project and closing it out. The focus of this role will be on managing quality initiatives that are necessary for new product introduction, compliance remediation, and to prepare for Regulatory inspections by the FDA and global agencies.
 
 
Note: This position is expected to be on-site at College Station Texas, with some remote potential.

 RESPONSIBILITIES:
  • Create project based Pre-Approval Inspection checklists
  • Lead the scheduling of tasks and execution of projects.
  • Ensure that the scope of the project is organized by deliverables, proper schedules are created and maintained, and that resources are managed to ensure timely completion of project elements.
  • Organize, lead and facilitate cross-functional project teams.
  • Provide a standard agenda and meeting summaries (discussion points, decisions, action-risk log).
  • Implement a project team meeting cadence which enables appropriate internal discussions and engagement/communication.
  • Assign and track specific functional accountabilities.
  • Follow up on Deviations and CAPAs as applicable
  • Actively conduct risk management within and across programs
  • Track and report program performance
  • Track, report &; pareto delays
  • Develop key performance indicators and report status at a minimum monthly to Azzur leadership as well as client leadership teams.

Mindset / Behaviors / Culture:
  • Ongoing prioritization, risk management & decision making, conflict resolution; integrates customer requirements, contract knowledge & input from functional experts to drive execution, decision making and team ownership/accountability.
  • Focused on productivity, efficiency, simplification
  • Strong verbal, written & presentation communications (one-on-one, teams/group, internal & client); effectively engages, facilitates, influences & motivates business & technical audiences.
  • Business acumen – working knowledge of drug technologies including vaccines, cell and gene therapy, and current Regulatory standards.
  • Customer focus – builds & maintains collaborative working relationships with clients and internal colleagues and stakeholders; solicits and responds to client and internal stakeholder feedback; respectful of others across functions & levels;
  • Actively engaged, action-oriented, resilient, passionately neutral in leading programs & teams
  • Recognizes & thanks individuals and teams for jobs well done.   

REQUIREMENTS:
  • BS in chemistry, biochemistry, engineering or microbiology
  • Master’s degree in relevant field is preferred.
  • Certifications preferred
    • Project/Risk Management certification (PMI-PMP, PMI-RMP) plus demonstrated practical experience.
    • Certified Quality Auditor or similar
  • 10+ years of demonstrated experience:
    • Managing 1-4 projects.
    • Interacting with Regulatory agencies and auditors
    • Building, refining, and improving quality management systems
    • cGMP & FDA regulations.
    • PAI Experience
    • Lead responses to Regulatory Inspections
    • Quality Risk Management
    • Leading-coaching-developing-motivating large cross-functional teams to achieve targeted results.
    • Problem solving & conflict resolution.
    • Knowledge of basic financial accounting.
    • Building trust, respect, and collaboration across the organization.
  • SharePoint, SmartSheet, and MS Office capability
  • Master Control, Compliance Wire, and Trackwise experience preferred
  • Strong verbal and written communication skills and comfortably and clearly articulate issues across the organization.


Azzur Group partners with leading pharmaceutical, biotechnology, and medical device manufacturers to provide efficient and innovative solutions that help them start, scale, and sustain their GxP organizations. With experts at more than 15 locations throughout the United States we take pride in our development and execution of phase-appropriate quality and compliance services to our clients From Discovery To DeliveryTM. 

Azzur Group is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. 



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