Assoc Director, Drug Compliance

Job Description Individual will oversee regulatory compliance and have responsibilities associated with products, testing, and distribution of bulk biologics at Biogen Idec's Cambridge and North Carolina manufacturing sites. Responsibilities include but are not limited to oversight to regulatory inspection preparation and outcomes, tracking commitments, internal audits and analysis of data, facilitation of risk assessment forums and participation in site Management Review Meetings. This candidate is expected to assume a strong leadership presence in Cambridge and with peers at other sites. The main focus is in GMP and Commercial Marketing and to a lesser extent GLP/GCP.
Essential Functions:
1. Manage a group of individuals from multiple sites involved primarily with the Biogen Idec internal compliance activities.
2. Evaluates data from audits and inspections; provides metrics reports and presents at management review; suggests priorities and improvements to the Quality System based upon the analyses; benchmarks with others in the industry for solutions to compliance risks.
3. Leads and participates in internal/external audits as required. Mentors junior staff meembers on audit technique and process.
4. Develops internal global documents as required to complement/improve the current processes and procedures.
5.Collaborate with business area experts to ensure awareness of and mitigation of compliance risks.
6. Reviews global documents for compliance with regulations, internal policies and the Quality Manual.

Qualifications
Excellent working knowledge of US regulations pertaining to GMPs and Commercial Marketing and Compliance; experience interfacing with regulators.
Previous experience working in biotech, biopharmaceutical and/or drug companies.
Strong communication skills, both verbal and written.
At leaste 10 years experience in Quality/Compliance, 5 years auditing, and 5 years managerial experience with oversight to senior level personnel.

Education
BS Life Science or Equivalent
Advanced degree in Life Science, Quality Operations, Regulatory Compliance or Business.