Lead Investigator

The Lead Investigator leads the complaint investigations and trending process for Client products, including Devices, Combination Products, and Drug Delivery Systems, with a focus on the Port Delivery System (PDS). The Product of accountability includes complaint investigations where material was used in clinical trials or supplied to the commercial market. The overall aim of this work is to respond to issues in the market (or clinic) and to identify trends and issues that affect the overall state of control of products and their manufacturing process, and, if necessary, identify appropriate actions for product quality issues.

Additionally, the Lead Investigator:
Responsible for executing, reviewing and approving records in the Quality Management System (including Complaints, Deviations, CAPA, etc.).
Identifies, analyzes, and drives the resolution of complex issues related to or identified with complaints processes.
Provides training and guidance as needed regarding the complaints process, including planning and the implementation of procedures.
Contributes to performance metrics and overall Quality assessment and reporting as part of the complaints business process.

Primary Duties and Responsibilities
The primary duty and responsibility of a Lead Investigator is Complaints Handling, which includes the following activities:
Lead product complaint investigations (critical and non-critical) with minimal guidance and ensure investigation action plans and final investigation summaries are accurate, include appropriate corrective actions, and follow company standards.
Collaborate and influence cross-functional departments (e.g. Affiliates, Manufacturing/Packaging Sites, Device Quality) to establish appropriate, efficient, and timely investigation strategies.
Lead and facilitate root cause analysis, and effectively present findings and recommended actions at QRB.
Manage Global Complaints for Devices, Combination Products, and Drug Delivery Systems that were manufactured, packed, labeled, or shipped by Clinical and Commercial Supply or on behalf of Global Clinical Supply and Global Supply Chain.
Initiate, coordinate, and track complaints as Lead Investigator or act as complaint QA and close/approve complaints.
Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.
Develop solutions to product complaint issues and Quality initiatives with inter-organizational impact following cGMP regulations, Legal Manufacturer requirements, and Client standards.
Lead department project teams to resolve product complaint process deficiencies.
Assess the accuracy of root cause determinations based on a thorough evaluation of possible failure modes.
Present product complaint records and/or reports during periodic audits and regulatory
inspections.
Communicate with patients and Health Care professionals, as needed.
Serve as the Quality representative on cross-functional and multi-site teams.
Identify, design, and implement department or cross-functional business process improvements.
Analyze complaint information and identify potential Quality issues including performing trend analysis.
Collaborate with key stakeholders to foster effective interdepartmental and cross-functional partnership solutions.
Collaborate and influence department procedures (e.g. SOPs, FNs, etc.).
Act as a mentor to and proactively train personnel and internal customers on relevant
business processes, fostering a culture of quality and continuous learning.
Review completed complaint files to assure proper documentation, coordination, investigation, resolution and closeout and ensure compliance to regulatory requirements as well as business requirements.
Create risk metrics on failure modes and complaint-related CAPA trend analysis records; and submit data to management to ensure early detection of potential quality issues.
Gather data to assist with any potential recall and/or reporting actions.
Monitor complaints for product trends and notify management of events requiring immediate action.
Support continuous improvement activities and projects (e.g. Quality systems support, batch record review) in accordance with applicable regulations and business goals and objectives.
Write, review, and approve CAPAs to ensure timely resolution of quality problems.

Education and Experience
B.A., B.S., or Higher degree (preferably in Life Sciences) with 8 years of relevant experience in the pharmaceutical, biopharmaceutical, or medical device industry.
Experience with technical writing.
Technical expertise in small and large molecule drug substance and drug product manufacturing processes as well as their associated control systems. Advanced knowledge of Medical Devices, Combination Products, and Drug Delivery Systems is required for this global role.
Experience with using quality-related tools, including Six Sigma / DMAIC, for problem solving and decision making.
Experience collaborating in a global setting to support product teams and global quality initiatives.
Experience with enterprise database, collaboration platforms, and analytics (IT platforms).

Knowledge/Skills/Competencies
Demonstrates strong knowledge of GMP, Quality Systems, Global pharmaceutical/biotechnology industry regulations, Health Authority regulations, and Client standards and guidance documents. This includes the ability to apply this knowledge to interpret and relate quality standards for implementation and review.
Demonstrates experience in Quality and pharmaceutical or biopharmaceutical manufacturing.
Demonstrates strong knowledge of analytical data, critical thinking skills, proficiency in the application of statistics and proficiency across technology platforms.
Demonstrate capability of managing Product Complaints, Sample Retrieval, Investigations, CAPAs, and Reconciliation.
Demonstrates excellence in communication. Must communicate clearly and professionally both in writing and verbally, including effective facilitation skills. Fluent in English.
Ability to lead communication with other groups on projects and initiatives.
Ability to build relationships and work with global interdisciplinary teams.
Demonstrated ability to work effectively in cross-functional teams to resolve complex technical, quality, and business-process related issues. Possesses exceptional collaboration and influencing skills to achieve optimized business results without formal authority.
Drives continuous improvement and operates with a Lean and Agile mindset.
Demonstrates resourcefulness, proactive dynamic learning potential, matrix leadership, and accountability.
An additional language proficiency to support Client network regional collaboration preferred.

TRAVEL REQUIREMENTS
Ability to travel according to the needs of the business (estimated 5% or less).