QA Device Lead

Job Description

About This Role

This person is responsible for the oversight of all Quality Assurance aspects supporting the implementation of design and manufacture of medical devices and combination products. This person is the primary interface between the design and development team and the greater Quality organization in support of implementation of GMP aspects of the design in Biogen’s validated business systems. This includes oversight of activities performed supporting late-stage development such as manufacturing and testing at partners of Biogen’s clinical and commercial assets that involve medical devices and/or combination products. This person will be the primary quality contact for GEQ/Site Quality on design and development teams, responsible for QA oversight of late-stage design deliverables and completion of design transfer. This person will also be responsible for evaluating and leading lifecycle management projects as applicable. As the Device SME, this person will also be responsible for executing transactional activities related to quality operations and management at our CMOs that manufacture medical devices, combination products and/or FG consumables, components, and subassemblies. Core responsibilities include but are not limited to: product design transfer / process transfers, scaleup / validations, product disposition, exceptions (deviation, CAPA), change control and risk management. This person may also lead and/or support continuous improvement initiatives related to Biogen’s QMS and procedures for CMO and partner oversight. This position collaborates with multiple internal and external functions to ensure compliance with cGMP regulations and Biogen QMS. Success in the role requires a strong knowledge in the application of phase appropriate, risk-based quality principles as it relates to medical devices and combination products.

WhatYou’llDo

1. Primary QA oversight for late stage device design and development deliverables including completion of transfer stage deliverables. Core member of design and development team. Oversee quality aspects of GMP activities for product manufactured and tested at Biogen’s CMOs. Manage the QA interface with manufacturing and testing partners to ensure on-time compliant manufacturing and testing.

2. Responsible for implementation of design in Biogen’s validated systems such as PLM, trackwise, and oracle.

3. Responsible for quality aspects related to tech-transfer, scale-up and process /analytical method validation as it relates to unit operations for the manufacture of product, including lifecycle management and Post-Marketing Commitments.

4. Perform functions and make decision consistent with cGMPs, Good Distribution Practices (GDP) and Biogen's quality governance. Ensure that the CMOs maintain quality systems that are in the state of compliance.

5. Perform risk assessments in response to product / quality system failures, investigations and regulatory inspections.

6. Provide Device Quality expertise to influence and support decisions across the Biogen Supply Chain.

7. Support internal audits, external audits of CMOs and regulatory inspections at CMOs as needed.

Who YouAre

The main purpose of this role is to provide a direct connection between the design and development of medical devices and combination products with the GEQ organization, ensuring compliant implementation of design in Biogen’s validated systems. Further, this role will be established as a Device SME and will be responsible for leading Lifecycle management programs, and post marketing commitments for medical devices and combination products. This person is responsible for facilitating all quality transactional activities needed to plan, allocate, make and disposition medical components, FG consumables and subassemblies of device constituents. This person is held responsible for ensuring that the quality of product meets GMP standards, Biogen standards, specifications and is compliant to the regulatory filing. This person will execute on but will not be limited to the following quality operations: deviations management and investigations, CAPAs management, change management, metrics tracking, SOP writing, risk assessments, internal and external audit support, inspection support, submissions review, recall / withdrawal and product complaints support. Other responsibilities include the evaluation of the general performance of CMOs and the identification, negotiation, implementation and follow-up of process and systems improvements needed for gained efficiencies and compliance.

Qualifications

Required Skills
  • Minimum, a BS degree. Life Sciences, Engineering or related field preferred, MS preferred
  • Minimum of 8 years in pharmaceutical/biotech industries.
  • Experience in one or several of the following fields: quality manufacturing, packaging, laboratory experience including, vendor management and clinical quality operations
  • Strong knowledge in the application of phase appropriate, risk-based quality principles as it relates to medical devices
  • Ability to develop strong relationships with internal and external stakeholders and counterparts
  • Strong working knowledge of design controls, manufacture and assembly
  • Comprehensive knowledge of US and EU GMP, GDP and MDR regulations




Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.

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