Job Description

The Specialist for Complaints at the S-12 Cell Therapy Manufacturing is responsible for the process and system ownership of the Product Quality Complaint (PQC) quality system module. In this role, the incumbent will serve as business process owner for the 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. In this capacity, the Sr Complaints Specialist will be the primary subject matter expert for GMP change control across the company.

REQUIRED COMPETENCIES:
Knowledge, Skills, and Abilities:
• Must have expert GMP, Quality, and in-depth risk management knowledge, particularly in the area of Product Quality Complaint handling.
• Must have an operational knowledge, including life cycle management experience, of common electronic quality system platforms, preferably EtQ, CelDox, and Compliance Wire.
• Must complete tasks independently and be confident in making complex decisions in their subject matter area, consulting with supervisor for decisions outside of established processes.
• Will interact with and influences across multiple departments and sites.
• Shall lead Site Lead team and drive performance and results.
• Must be able to conceptualize broad impact of system related initiatives and recognize quality issues.
• Must be a problem solver, actively seeking management guidance on complex issues.
• Shall be able to effectively prepare communications to the customers and management in a productive manner with clarity, brevity, and accuracy.
• Must be able to conceptualize broad impact of Quality on sites and/or departments and participate in Quality initiatives.
• Must be familiar with the roles and responsibilities of common GMP functional areas such as Quality, Manufacturing, Packaging Development & Commercialization, Drug Safety, and Medical Affairs.
• Must be action-oriented and customer-focused and skilled in the following areas:
o communication
o relationship building
o problem solving and negotiation
o conflict management
o planning and organizing
o resource allocation
o analytical thinking
• 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.
• 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).
Education and Experience: • Relevant college or university degree in a scientific and/or clinical area of study preferred.
• Minimum 7 years relevant work experience and minimum 3 years of leadership experience.
• An equivalent combination of education and experience may substitute.

DUTIES AND RESPONSIBILITIES:
• Function as the Quality System Owner for the PQC system and all associated processes and procedures. Serves as subject matter expert for the business process and associated electronic system.
• Plan and implement lifecycle changes and system level enhancements through partnership with IT Developers and Business Analysts.
• Author and maintain all standards, policies, procedures, work practices and job aides that support the PQC system in both the Commercial and Development areas.
• Develop and conduct user training and manage system access.
• Provide input to and execute the strategic roadmap for the electronic PQC module in Electronic Quality Management System.
• Represent PQC as SME and process owner in a front-room capacity during all internal and third-party audits/inspections.
• Create and distribute all metrics, analytics and performance indicators for PQC.
o Provide support of Adverse Event surveillance processes with Global Pharmacovigilance.
• Collaborate with cross-functional system partners and represent the PQC user community in all governance and life-cycle related capacities.
• Own and implement a consistent and effective document hierarchy plan for the PQC system, including local and global elements.
• Identifies and applies all regulations, guidance documents and industry best practices related to the Product Quality Complaint system.
• 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 PQC transactional tasks including but not limited to:
o Input of PQCs into the electronic complaint system
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.
• Performs other tasks as assigned

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 30% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc. This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management

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Job Types: Temporary.

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