Position OverviewPosition Description We are hiring a QA Commercial Manager. The QA Commercial Manager will oversee communication of quality information to external and internal customers. This may include, but is not limited to: change notifications, surveys, qualifications, customer quality incidents, supplier management (qualification and re-evaluation), audits (internal, supplier & customer), and management of customer support related to Quality related questions. This position manages two main groups: QA Support and Audit Management.
Job DescriptionResponsibilities:- Oversight of QA Support group and Audit management group, including functions, planning, systems, and personnel
- Coaches, trains and helps personnel within the group to grow and advance in their knowledge and job function
- Ensures customer communication is completed fully and in a timely manner
- Reports and tracks department activities to ensure KPI's are met
- Helps customers obtain requested information (RFQ, master files, quality questions, investigations, certificates, trending, summaries, follow up, etc....)
- Acts as customer liaison for internal inquiries and provide voice of customer
- Manages customer surveys, issues, and questionnaires completion
- Manages supplier questionnaires and qualification
- Manages global change notification program, including coordinator for FLBI-PA, LSM and Toda sites
- Manages audit program, both internal and external (vendor audits); as well as acts as customer audit host
- Ensures audits (both internal and external) are performed as planned, responded to, and their actions are completed per the agreed upon timeframes
- Manages supplier management program (including but not limited to: qualification, re-evaluation, material qualification, performance monitoring)
- Assist with coordination of quality activities for Global FLBI production sites, including but not limited to FLBI-PA, LSM and Toda.
Required Skills/Education: - BS/BA in Biology, Microbiology, or Chemistry preferred
- Minimum 5 years of QA experience in medical device or biopharmaceutical environment
- Minimum 2 years of People Management experience with direct supervision of a team
- Must be familiar with FDA's GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC, Health Canada and MDR requirements.
- Excellent computer skills including MS Word, Excel, PowerPoint
- ISO 13485 or 9001 lead auditor certification preferred
- Ability to speak, read, and write proficiently in English.
- Good oral and written communication skills.
Salary and Benefits:- For California, the base salary range for this position is $106,185.25 - $138, 230. 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
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