Associate Director, QC Program Management

Overview

The Associate Director for Quality Control (QC) Program Management should be able to work effectively, independently and within a team framework, across all business areas, levels of the organization, and with clients by delivering high quality at the right time  to ensure timely delivery of QC services.  This role requires that you can operate on both a strategic level with senior executives and to facilitate operational elements in the actual program execution.

External US

Major Accountabilities:

 

• Primary QC liaison and project team member between the client and FDBN.
• During project phase of the site, responsibilities may include leading project management initiatives for the QC department to meet project timelines.
• Lead the planning and execution of programs for QC in alignment with Quality Agreements (vision, mission, strategy-goals-objectives) and Analytical Method Capabilities of FDBN.
• Organize, lead, and facilitate QC project teams including meeting cadence for each program by providing a standard agenda and meeting summaries (discussion points, decisions, action-risk log). Implement a project team meeting cadence which enables appropriate internal discussions and client engagement/communication.  Assign and track specific functional accountabilities.
• Provide timely responses to clients including but not limited to communications involving operational readiness for analytical capabilities, request for information from client and serve as primary point of contact to clients for QC related deliverables.
• Support the commercial team in the initial draft Scope of Work (SOW) related to QC analytical methods and engages impacted QC functional areas for inputs to ensure the analytical method transfer and validation expectations are complete and realistic.
• Lead, coordinate, and facilitate meetings between clients and QC tech transfer leads to ensure high performance of QC activities.
• Represent QC in cross-functional meetings and partner with all FDB QC teams involved in the customer collaboration.
• including but not limited to: Program Kickoffs (Internal & Client), Project Teams, and steering committee membership (as needed)
• Establish and oversee external relationships with contract laboratory organizations (CLOs) for QC.
• Drive project management initiatives for QC related to tech transfer of analytical methods, CLO management, and ensuring QC team meets deadlines for client commitments.
• Support the generation of contracts and amendments to Quality Agreements, Statements of Work, and Master Service Agreements together with the global Commercial Development team and Quality Assurance.
• Adhere to the global quality system and support handling of tasks in accordance with Statement of Works and Quality Agreement.
• Drive/participate at Quality management meetings where relevant Key Performance Indicators are shared.
• Participate in initial meetings with customers together with Analytical Development for the technology transfer and Quality Control activities from a QC customer perspective.
• Develop and manage a culture of mentorship, professional growth, skill development and career advancement within the team.
• Create, organize, and communicate status of projects to clients, QC teams, and senior leadership using project management tools.
• Other responsibilities as assigned.

Minimum Requirements:

• Bachelor’s degree required, preferably in Chemistry, Microbiology, Biological Sciences, Engineering or related science degree.
• 15+ years of analytical laboratory experience preferably in biotechnology, research & development, Pharma, Contract Research Organization (CRO), or Contract Laboratory Organization (CLO), with experience in a regulated environment.
• Experience managing projects, programs, or portfolios related to analytical laboratories, research & development, Biotech, CRO, CLO or Pharma industry.
• At least 5 years of management experience is required.
• Requires knowledge of GMP and quality systems.

 

Preferred Requirements:

• Experience with project/program/portfolio management.
• Experience with Customer Relationship Management.
• Understanding of analytical methods and working in a GLP or GMP laboratory.
• Strong verbal and written communication skills and comfortably and clearly articulate issues and driving problem solving across the organization.
• Experience with Leading--coaching-developing-motivating large cross-functional teams to achieve targeted results.
• Understand importance and feels confident with building trust, respect, and collaboration across the organization.