Manager, Technical Investigation

We are hiring a Manager of Technical Investigations. The Manager of Technical Investigations 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.

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.

Required Skills/Education:

• 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.
• Additional language skills are preferred.
• Good oral and written communication skills

Salary and Benefits:

• For California, the base salary range for this position is $103,093 – $134,204. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).
• Medical, Dental, Vision
• Life Insurance
• 401k
• Paid Time Off