Summary:

The Quality Assurance Manager plans and develops activities and programs for the U.S. subsidiary to ensure compliance with BOIRON quality and regulatory standards as well as cGMP.

Responsibilities:

• Manage BOIRON USA quality systems.
• Recruit, train, and develop Quality Assurance staff members;
• Evaluate resource needs and propose development plans to senior management;
• Manage quality initiatives in conjunction with international QA counterparts in Europe and worldwide.
• Identify opportunities for continuous improvement in QA and Quality Control activities as they relate to distribution branches and BOIRON USA Headquarters
• Provides customer-focused representation of BOIRON, and will demonstrate self-reliance, flexibility, and goal-orientation, and a desire to work collaboratively to accomplish team objectives and advance BOIRON’s mission.
• Manage third party audit programs, both internally and externally;
• In conjunction with Regulatory Affairs, oversees/manages all inspections by regulatory agencies;
• Responsible for the development, review and approval of Standard Operating Procedures (SOP’s);
• In conjunction with Engineering, Information Technology, Manufacturing, and counterparts in BOIRON France, responsible for design, execution, and documentation of validation projects for processes, equipment, facilities and computer systems;
• Organizes and maintains documentation related to compliance with regulations;
• Approval of specifications for finished products and component parts;
• Auditing of BOIRON and vendor sites;
• Employee training program development and management;
• Conduct training related to QC/QA and GXP activities;
• Advising on and managing product Quality Complaint investigation and resolution;
• Manage documentation Change Control program;
• Conduct, review and approve investigations into deviations, complaints, non-conformities, and out of specification testing results;
• Manage, approve and oversee domestic packaging processes and documentation;
• Approval of Master Packaging Instructions and batch records as needed;
• Liaison to contracted analytical laboratories as needed;
• Vendor qualification and evaluation program management;
• Management of technical product data;
• Perform other duties as assigned.

Requirements:

• BS/BA degree in a life science area is required.
• Master’s degree is desirable, but not a requirement.
• A minimum of (5) five years experience in the pharmaceutical industry or a related cGMP environment is required.
• A minimum of (2) two years supervisory experience is required.
• Ability to travel domestic and international (occasionally) locations (up to 25% travel required), which may include overnight and/or weekend travel.
• Strong analytical and problem-solving skills.
• An ability to work independently to manage activities and tasks.
• Positive communication and interpersonal skills.
• Highly organized with strong follow through and time management.
• Detail oriented.