Director Product Quality Management

As Director Product Quality Management:

The Director Product Quality Management Complaint Investigation Manager position will report to the Senior Director of PQM Strategy Deployment & Excellence and is responsible for investigation, documentation and resolution/closure of Product & Signal Complaint Investigations, Nonconformances and/or CAPAs identified through PQV established processes.

The responsibilities and the impact YOU will have:

• Act as complaint investigation process SME by providing technical, quality and compliance expertise for investigation, documentation and resolution/closure of Product & Signal Complaint Investigations within the PQM Team.
• Ensure that deviations & complaints are timely and properly investigated such that the internal and external customer expectations are met.
• Lead the application and integration of structured root cause problem‐solving methodologies to (Fishbone, 5 Whys, etc.) to all Product & Signal Complaint Investigations identified through PQV established processes.
• Act as process SME for Nonconformances and/or CAPAs raised as part of Product & Signal Complaint Investigations identified through PQV established processes.
• Work directly with PQIs/PQOs and device engineers’ teams to ensure product knowledge of Synthetics, Proteins and Cell and Gene therapies are core to all end of end Root Cause Analysis investigations.
• Work as part of a cross functional Investigation team to drive critical thinking and end-to-end accountability of product and signal complaint investigations.
• Work with the organization to identify resources to support RCA investigations and resulting actions.
• Develop and maintain proficiency in the COMET.
• Monitor nonconformance and CAPA deliverables / timelines for functional area by running reports, communicating upcoming deadlines to record owners and escalating concerns to management as appropriate to actively drive compliance.
• Escalate any issues, as needed, to the PQM CAPA Review Board and attend the meetings if required.

General Skills

• Problem solver, who has excellent written and verbal communication skills.
• Excellent independent time management skills, with a proven ability to plan and track deliverables and timelines.
• Ability to work well in a dynamic environment and able to prioritize and respond to changing needs of the business.
• Highly committed to quality, flexibility and persistence.
• Good conflict handling/negotiation skills, who’s able to create win-win situations with internal and external partners.
• Knowledge of corporate structure and culture.

We would love to hear from YOU if you have the following essential requirements:

• Requires a BA/BS in Science/Engineering. Master’s degree in life science study or equivalent experience is preferrable,
• Minimum of 7 years’ experience previous Pharmaceutical Industry experience is required, with at least 7 years of GXP experience within clinical research and development and/or quality assurance.
• Up-to-date knowledge and in-depth understanding of relevant pharmaceutical legislation, legislation related to cGMP regulations (Eudralex, ICH, Ph.Eur., USP, etc) at global, regional and national levels.
• Strong analytical thinking, decision-making and leadership skills.
• Excellent verbal and written communication skills to negotiate and communicate with customers and partners.
• Able to apply appropriate risk assessment strategies to manage business & compliance priorities and translate them into actionable items and an action plan.
• Fluent in English.
• Proficient in Microsoft Office applications.

Hybrid Work