Manager, Global Quality Systems, Product Quality Complaints
Newark Metro Area, NJ
The Manager, Global Quality Systems Product Quality Complaint (PQC), is responsible for process and system ownership of the Product Quality Complaint (PQC) quality system element. In this role, the incumbent will serve as business process owner for the eQRMS electronic complaint handling module and associated governing procedures. This is a highly visible role with global responsibility and cross-functional influence that has a high impact on departmental performance and broad quality initiatives requiring both strategic and tactical decision making.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
Function as the Quality System Owner for the Product Quality Complaint system and all associated processes
Must have expert GMP and Quality knowledge, particularly in the area of Product Quality Complaint handling.
Must be able to function as SME for Product Quality Complaints within the organization.
Must be familiar with the roles and responsibilities of Drug Safety and Medical Affairs within a pharmaceutical/biopharmaceutical company.
Must have an operational knowledge, including life cycle management experience, of common electronic quality system platforms, preferably EtQ, Documentum, and ComplianceWire.
Must be able to effectively prepare communications with interpretation of data analysis and potential problems to appropriate audience, with clarity and a high level of accuracy.
Must provide guidance to other employees in the interpretation of technical/scientific issues across the job function and manage development of technical/scientific initiatives and activities by interdisciplinary teams.
Most have a strong technical writing skill set and be able to critically review reports while effectively inputting and expressing Quality risk management principles.
Must be action-oriented and customer-focused and skilled in the following areas:
o building relationships
o problem solving
o conflict management
o planning and organizing
o analytical thinking.
Must be able to operate with minimal direction to complete tasks, consulting with supervisor for decisions outside of established processes.
Supervision of Staff Specialist
o Objective setting, coaching and development of staff
o Delegation and prioritization
Must have a thorough knowledge of PC productivity tools such as Word, Excel, PowerPoint, and Visio (Expert knowledge in the utilization of Excel is preferred).
DUTIES AND RESPONSIBILITIES
Function as the Quality System Owner for the Product Quality Complaint system and all associated processes and procedures.
Author and maintain all standards, policies, procedures, work practices and job aides that support the PQC system ensuring all documents and processes comply with applicable regulations, guidance documents and industry best practices.
Serve as the subject matter expert for the GMP business processes and associated electronic systems.
Identify need for, plan and implement lifecycle changes and system level enhancements through partnership with IT Developers and Business Analysts
Develop user training and manage system access for consistent delivery of material.
Provide input to and execute the strategic roadmap for the electronic Product Quality Complaint module in eQRMS.
Represent Product Quality Complaint as SME and process owner in a front-room capacity during all internal and third party audits/inspections.
Create and distribute globally assigned metrics, analytics and performance indicators for Product Quality Complaints.
Collaborate with cross-functional system partners including but not limited to Drug Safety, Medical Information, Customer Care/REMS, Technical Operations and domestic/international Affiliates.
Own and implement a consistent and effective document hierarchy plan for the PQC system, including local and global elements.
Establishment and maintenance of Complaint Trending and Complaint Threshold programs
Benchmarks through industry associations, system vendors etc. to ensure business processes and systems are consistent with industry best practices
Supervise the execution of day-to-day Product Quality Complaint transactional tasks including but not limited to:
o Input of PQCs into the electronic complaint system (eQRMS)
o Review of received complaints and collaborate with intake/initiator groups
o Complaint classification and severity assignment
o Unit trending
o Facilitation of sample return with the logistics team for sample assessment
o Issuance of Management Notifications for critical complaints
o Generation and distribution of customer response letters, as applicable.
EDUCATION AND EXPERIENCE
Relevant college or university degree in a scientific study preferred.
Minimum 7 years relevant work experience in a GMP Quality organization and a minimum of 3 years of supervisory experience.
Previous experience working with Product Quality Complaint process required. An equivalent combination of education and experience may be acceptable.
WORKING CONDITIONS: (US Only)
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc