Job Description

Quality Assurance Manager at Boiron USA

Must be able to commute to Newtown Square, PA for hybrid schedule

What does Boiron Do?

For over 85 years, Boiron has been dedicated to providing families with the purest medicines made from the earth's best resources. As a leader in the natural health and wellness space, Boiron offers solutions for common ailments such as cold, allergies, heartburn, muscle soreness and many more. You can find Boiron products in top retailers nationwide.

What would you be doing as a Quality Assurance Manager?

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.

But what does this role really do?

• 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.

You would be a great fit if you have the following...

• 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 to domestic and international (occasionally) locations (up to 25% of 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.

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