SUMMARY:

The Manager of Quality Operations is responsible for providing quality oversight to all manufacturing operations in support of clinical development and commercial products, including but not limited to, Drug substance, Process Intermediates, and Drug Product(s). This role requires interaction with Clinical Operations, Pharmaceutical Operations, Program and CMC project management, Regulatory Affairs, Supply Chain, and CMOs.

RESPONSIBILITIES:

• Provide quality oversight to all manufacturing operations in support of clinical development and commercial products. Ensure all manufacturing activities in support of Drug substance, Process Intermediates, and Drug Product(s), are conducted in accordance with internal company standards and in compliance with quality agreements.

• Administering policies and standard operating procedures (SOPs) relating to the Quality Operations function. Identify opportunities for improvements.

• Real time batch record review and resolution of associated deviations prior to product disposition.

• Manage Deviations and Change Controls at the CMO sites.

• Assist with delivering quality training for the team.

• Provide all required documentation in support of the Annual Product Reviews

• Review of CMC sections for regulatory submissions to ensure accuracy and completeness. Participate in activities to assist with regulatory submissions, control strategy development and CMC strategy.

• Quality review of Technology transfer protocols and final reports.

• Help with the Preparation and assist during regulatory inspections at the CMO sites.

• Using incident and Corrective and Preventive Action (“CAPA”) activities and processes to drive quality improvements and respond to process and service issues.

• Implement short-term and long-term strategies, goals, and objectives related to the Quality Operations function and the quality management system

• Review and recommend appropriate corrective action to ensure consistency with the Quality Operations function and the quality management system

• Represent Quality Operations function in connection with internal or external audits, inspections, , and provide quality-related information related to (but not limited to) client assessments, RFPs, contracts and other documentation

• Maintain current knowledge base of regulations, corporate policies and standards to ensure that the Quality Operations function remain in compliance with applicable regulatory and corporate standards/requirements and current with industry trends and best practices

• Identify risks and assumptions in plans, anticipate problems and plan for contingencies. Remove obstacles to move work forward and/or to get efforts back on track.

SKILLS, EDUCATION AND EXPERIENCE:

• Bachelor's Degree is required (Biological sciences, Engineering or related degree); advanced degree is a plus

• Minimum of 5 years related experience in the Pharmaceutical/Biopharmaceutical/Biotechnology industry.

• Ideally a minimum of 3 years of experience in leading a Quality function, preferably at the manager/supervisor level.  

• Proven ability to effectively develop, communicate, and gain support for execution plans with team members from other functions.

• Management skills to grow and manage a high performing Quality organization.

• Desirable to have skills in project management and working with vendors and contractors

• Background in FDA, ISO, EMA, GMP and ICH requirements ideally for ATMPs.

• Familiar with regulatory submissions, ideally for products which were ultimately approved for commercial distribution, and regulatory inspections.

• Interpersonal skills, organizational skills, written and oral communication skills

• Ability to work in a fast paced and dynamic environment that will require management of several competing priorities while driving all projects forward and meeting program/project deliverables

• Energetic, flexible, collaborative and proactive; a leader who can positively and productively impact initiatives

.AVAILABILITY:

• MUST BE AVAILABLE TO WORK IN THE EVENINGS AND WEEKENDS, AS REQUIRED.

POSITION LOCATION AND/OR TERRITORY AND TRAVEL 

• Position is located in Irvine, CA or Cambridge, MA
• Position may require up to 20 % travel and occasional local travel

SPECTRUM PHARMACEUTICALS is an equal opportunity employer. We evaluate qualified applicants without regard to race, color. Religion, sex, national origin, disability, veteran status, and other protected characteristics.

Required Skills Required Experience