Manager of Tech Investigation

Fujifilm•Santa Ana, CA

59d•Onsite

About The Position

We are hiring a Technical Investigations Manager. The Technical Investigations Manager will oversee collection, documentation, and management of all customer complaints and inquiries to ultimate resolution, working cross-functionally with internal teams where needed. They will communicate with customers, sales, marketing, customer service and applicable internal teams and act as a key voice of customer and ensure that customer feedback is fed back into the business. They will also engage and ensure appropriate product compliance in line with SOPs and RA/QA requirements.

Requirements

Bachelor’s Degree in Biology, Biochemistry, Cell Biology, Microbiology, Chemistry or related field. Higher level educational degrees (Master’s Degree or Ph.D.) are highly desirable and may count towards experience.
Five (5) or more years of experience in Technical Support, Quality Engineering or Quality/Regulatory Compliance in biotechnology, pharmaceutical, medical device or related industry.
Two (2) or more years of direct supervisory or management experience.
GMPs, USP, ISO Quality Management Systems ISO 9001 and 13485.
Familiarity with Quality control methodology including analytical methods such as pH, osmolality, HPLC and ICP-MS, QA control systems and production methodologies.
Hands-on mammalian cell culture experience
Knowledge of cell culture media biochemistry. Experience can be from education or industry.
Ability to obtain cooperation from other groups and lead cross functional teams.
Strong critical thinking, analytic, strategic and creative problem-solving skillset
Experience with risk management and Failure Mode Effects Analysis (FMEA).
Strong root cause analysis skills required (5-Why, fishbone, fault-tree, etc).
Proficient in Microsoft Word, Excel, PowerPoint, Outlook, Power BI and Enterprise Resource Planning systems.
Leadership, people management and decision making.
Financial Management.
Excellent communication skills in writing and presenting
Ability to organize complex information and generate clear, concise, management-level reports.
Ability to speak, read and write English proficiently.

Nice To Haves

Higher level educational degrees (Master’s Degree or Ph.D.) are highly desirable and may count towards experience.
Additional language skills are preferred.

Responsibilities

Manage and mentor Technical Investigators, ensuring timely, accurate, compliant, audit-ready and in-budget investigations. This includes providing solutions to customers' technical challenges, troubleshooting issues, and addressing any concerns raised by customers
Perform triage assessment of customer cases; determine the nature of direct and indirect customer inquiries and classify them for resolution.
Based on competing demands and new information, rapidly reprioritize activities as needed.
Guide the team in generating and testing hypotheses to determine root causes.
Oversee documentation review relevant to cases including legal agreements, batch records, QC data and commercial and shipping documentation.
Utilize the resources within the company such as QA, R&D, Manufacturing, Shipping and Customer Service to identify and confirm root causes.
Work collaboratively with internal teams, such as Sales, FASs, R&D and Product Management, to offer efficient and effective resolutions to customer inquiries.
Maintain compliance of: documentation intake, investigations, complaint review and approval, customer follow-up and communication, tracking, trending and reporting on program.
Ensure complaints are investigated closed within established timeframe.
Assess and evaluate training needs of direct reports; ensure training and development needs are met within department plans and budgets.
Ensure all corporate and departmental policies and procedures are understood and followed by self and direct reports
Ensure legal and ethical principles and policies are understood and followed by direct reports.
Advise management, in real time, of product technical matters for effective, accurate situational awareness and rapid escalation of issues as needed.
Foster and maintain the company's reputation as a technical resource and industry leader:
Verify that all customer communication is appropriate and professional and demonstrates scientific rigor.
Drive continuous improvement within the Technical Investigations team and within the organization to be at the forefront of knowledge and support
Collect customer feedback from complaints and technical interactions and synthesize trends
Define, monitor and have responsibility for meaningful metrics and KPIs, track trends and provide management-level reporting
Feed insights into New Product Development, Product Management and Strategic Marketing, Manufacturing, Raw Material Specifications and Continuous Improvement Programs
From field, customer and internal feedback, support Marketing and R&D to generate FAQs and technical notes as a resource for all product lines to support commercial efforts.
Develop relevant training to enable widespread adoption of technical information and methodologies for the commercial and support organization.
Manage, oversee and perform product Compliance activities, including, but not limited to the
Assess when complaint trending should trigger review for CAPA initiation. Provide the necessary data and support to the CAPA owner.
Revise or create Complaint Handling & Investigations SOPs based on feedback and data, as needed, and support cross-function departments on SOP updates for processes that involve the Complaint Handling & Investigations group. Make recommendations for SOP updates based on customer feedback or result of investigations.
Ensure all activities comply with applicable regulatory and quality standards (ISO 13485, GMP, FDA).
Assist in communication with regulatory agencies, notified body, and competent authorities as associated with Compliance activities.
Support customer and regulatory audits.