Director Product Quality Management

Johnson & Johnson Innovative Medicine•Malvern, PA

About The Position

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): [Beerse/Antwerp-Belgium, Leiden-Netherlands, Latina-Italy, Cork-Ireland] - R-050019 Director Product Quality Management [Schaffhausen-Switzerland] - R-050939 Director Product Quality Management [PA Malvern-USA, Raritan-USA] - R-050955 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.

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.
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.

Responsibilities

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.