Quality Systems Specialist II

Job Description:

As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our ‘people first’ philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world’s oldest enemy: disease.

With Ferring, you will be joining a recognized leader, identified as one of “The World’s Most Innovative Companies” by Fast Company, and honored by Fortune with inclusion on its “Change the World List,” for addressing society’s unmet needs. Ferring US is also Great Places to Work® Certified, distinguishing it as one of the best companies to work for in the country.

Job Summary:

Summary: The Quality Systems Specialist II is primarily responsible for establishing, developing, implementing and maintaining quality systems processes and programs to include: Supplier Quality, Audit, Investigation Systems, Periodic Product Review, Product Complaint, Regulatory Inspections, Document Control, Change Management, Training, and Technical Document review. This position may support one or many of the Quality Systems and Compliance functions.

Responsibilities:

Establish, implement, maintain the following Quality System areas to assure compliance to applicable regulatory requirements:

Supplier Quality Management System

• Manage suppliers of materials, parts, and services through a risk- based approach.
• Implement a supplier evaluation process to ensure adequate quality oversight and compliance of vendors and service suppliers by managing or conducting supplier questionnaires, performing external audits, and/ or establishing quality agreements.

Internal and External Audit Programs

• Perform internal and external audits

Investigation Systems and Planned Deviation System

• Establish systems cross functionally and provides oversight and review of Quality Event investigations (Nonconformance/failure, OOS, unplanned deviations, and CAPA)
• Mentor colleagues on root cause analysis techniques, and processes. Lead investigations for complex matters.
• Facilitate meetings, provide systems visibility, communicate status, and facilitate closure of aging items.

Periodic Product Review

Product Complaint

Management Review

• Gather quality performance metrics and coordinates Management review inputs from various contributing departments.
• Track, trend and report Quality System metrics to ensure continuous quality improvements while communicating critical compliance and quality risks.

Product Recall Program

Provides Quality System and Compliance oversight for internal and external customers, by working cross functionally, to ensure Quality System processes, compliance requirements, and improvement programs are implemented to meet drug/biologic cGMPs based on products regulatory phase.

Review and approve cGMP documents and/ or regulatory submission documents for compliance to internal procedures and applicable regulations.

Support the design and implementation of a robust and compliant framework of cGMP policies, procedures and processes.

Provides mentoring and guidance to the teams responsible for establishing Quality Management System elements in their functional area of responsibility to build a strong quality driven culture by collaborating with Manufacturing and Technical Operations, Materials Management, Quality Control, R&D and Regulatory.

Acts as a Quality team member to define and facilitate QMS implementation and continuous improvement activities.

Prepare and provide support for agency audits of Rebiotix (FDA or other.)

Supports preparation efforts for front room and back room activities for FDA Bioresearch Monitoring Inspection (BIMO), Pre-Approval Inspection (PAI) and Quality System inspections.

Supports the activities related to BLA submission, IND and other regulatory filings as applicable.

Provides review of CMC section(s) to ensure alignment with current procedures and/or supporting data/justification.

Performs cross functional alignment with Regulatory to meet FDA requests for information and Annual Review requirements.

Support other Quality functions

Support processes related to document control, change management, training, periodic review system/process, and record retention.

Su