Mission

The Quality Assurance Operations Manager will be responsible for the management of contract development and manufacturing organizations (CDMOs) for the manufacturing and release of all Beacon products. Provides quality oversight of internal and external activities, documentation, and processes to assure compliance with company procedures and applicable regulations.

Reporting Relationship

• Quality Assurance (QA) Operations Manager will report directly to the SVP, Quality Assurance and Regulatory Affairs or designee.

Duties and Responsibilities

• Interact and develop relationships with CDMOs and continuously improve all aspects of quality to achieve and sustain conformance to both internal and external requirements. Provide quality oversight and resolve quality related issues.
• Ensures the development, implementation, and improvement of corporate quality systems, policies, processes, procedures, validations, and controls to assure compliance with all applicable federal, state, and local regulations and industry standards that support early to late phase gene therapy clinical programs.
• Collaborate with various functions to perform QA oversight and ensure quality-related activities are executed efficiently.
• Identify, communicate, and escalate quality and compliance risks. Provide direction for and participate in timely resolution, acting always with an appropriate sense of urgency.
• Ensures independent QA review and approval of product-related documentation including batch records, OOS, Certificate of Analysis (CoAs), Certificates of Tests, and analytical test results.
• Provide timely issuance, resolution, and closure investigations (e.g. deviations), and Corrective and Preventative Actions (CAPAs) in response to supplier, manufacturing, and/or laboratory discrepancies. Provide QA leadership to assure thorough root cause investigations and effective corrective actions to prevent reoccurrence.
• Ensures effective and reliable disposition and release activities of batches produced within established timeframes.
• Perform internal audits, write audit reports, and prepare QA statements as needed.
• Perform QA review of temperature excursions and provide authorization for clinical material release for shipment.
• Participate in third-party audits and inspections conducted by state and federal regulatory agencies.
• Act as internal quality SME; participate in various cross functional teams as the QA representative.

• Track and trend quality metrics, analyze trends and identify and assure implementation of improvement initiatives. Track open deviations and CAPAs to closure. Report metrics for Quality Management Reviews.
• Other duties as assigned.
• This job description is subject to change at any time.

Educational Qualifications

B.S. degree in a scientific discipline or relevant discipline and five (5) plus years QA experience in a GLP/GMP environment in a biotechnology company. At least seven (7) years of experience is preferred.

Additional Qualifications

• In-depth understanding of GLP and GMP (drugs and biologics) regulations, guidance documents, systems, processes, and procedures
• Technical writing skills and problem-solving methodologies
• Great attention to detail
• Strong interpersonal skills
• Strong prioritization, organizational and negotiating skills.
• Excellent verbal and written communication skills and ability to communicate effectively with team members, peers, and management.
• Solid time management skills and ability to handle multiple tasks and deliver high quality results within set timelines.

Physical Requirements

• Physical activity: (check all that apply)

• Visual acuity (preparing/analyzing data, transcribing, reading, use of measuring devices, machinery labels, color differentiation, etc.)
• Working conditions (indoor/outdoor, noise levels, hazards, working quarters)

Supervisor Responsibilities

• This position does not require employee supervision.

NOTE: Agencies and Recruiters need not contact. Unsolicited resumes will not be considered.