Director - Supplier Quality - Biogen Idec - Cambridge

Job description
This position requires a dynamic individual who will represent Idec Quality cross-functionally within Biogen Idec and externally at contract manufacturing facilities in North America. The scope of this position is to develop and sustain a high performing organization providing quality oversight of the manufacturing of clinical and commercial API/drug product as well as continuous improvement initiatives. This position will manage the productivity and career development of a small team of 3 – 4 QA Associates.


Responsibilities include:

• Manage Supply Chain Quality activities at US contract manufacturing organizations (CMO) including product disposition, investigations, validation, Quality Agreements
• Participate in BIIB Health Authority audits and support Health Authority audits at contract sites
• Builds relationships and works closely cross functional stakeholders (Development, Supply Chain, Regulatory) and external partners to ensure alignment and compliance with Quality Strategy
• Assist in the development and continuous improvement of Quality Systems to ensure compliance with industry regulations, guidelines and trends within the Biogen Idec supply chain.
• Represents Quality at cross-functional meetings related to quality issues, investigations, initiatives

Qualifications
• Broad expertise in the principles and application of quality and regulatory compliance related to cGMP, ICH Guidelines, industry and regulatory trends
• Ability to deal with high levels of ambiguity, anticipating potential risks and develops corresponding risk mitigation plan.
• Practical knowledge of how to identify key performance metrics for quality indicators to set targets for maintaining a state of control while identifying areas for improvement
• Strong aptitude for facilitating group or project team endeavors, and building team unity
• Advanced ability to effectively communicate and influence the outcomes of the decision making process
• Highly effective coaching abilities as well as a successful track record of developing staff
• Minimum of 10 years Biopharmaceutical experience, with at least 5 years’ experience in Quality Assurance.
• Must have 5 or more years of experience managing direct reports.

Education
B.S. in Science or Engineering required; advanced degree preferred.

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