Director of Quality Control
Spectrum Pharmaceuticals, Inc.
The Director of Quality Control is responsible for designing, planning, implementing, directing and evaluating a quality Control function which support analytical development and regulatory approval of products. This role requires extensive interaction with Pharmaceutical Operations, Quality Assurance, Quality Operations, Program and CMC project management, Regulatory Affairs, and CMOs.
* Develop, implement, maintain and continually assess a quality control function and a quality management system for applicable regulated activities to meet internal company standards and external regulatory and customer requirements, including but not limited to, the following tasks:
* Plan and coordinate all the analytical R&D and quality control activities.
* Establish robust analytical development strategies, plans and timelines.
* Generate release and stability specifications for raw materials, drug substances and drug products.
* Manage method development and method validation activities for drug substance, drug substance intermediates and finished drug products.
* Review stability study design, monitoring, reporting and data trend-analysis.
* Perform clinical material evaluation and COA generation.
* Manage method transfer activities to contract manufacturing organizations/testing laboratories.
* Review/approve, methods, protocols, validation reports etc.
* Provide leadership for deviations and investigations at contract manufacturing organizations/testing laboratories.
* Formulating and administering policies and standard operating procedures (SOPs) relating to the quality control function and the quality management system.
* Establishing and maintaining a document control system for QC procedures, work instructions and forms
* Ownership of test record review and COA creation.
* Developing and implementing appropriate quality control training for the team.
* Provide training and guidance to analytical development best practices.
* Contribute to Annual Product Reviews.
* Prepare and review analytical sections of CMC for regulatory submissions and annual reports.
* Preparation and leadership for regulatory inspections.
* Implementing, performing and overseeing internal quality auditing of QC function (including applicable vendors or subcontractors), customer quality audit response, and other QC related quality management system activities.
* Define, develop and implement short-term and long-term strategies, goals, objectives and tactics relating to the quality control function and the quality management system.
* Review and recommend appropriate corrective action to ensure consistency with the quality control function and the quality management system.
* Implement a continuous improvement plan for growing and maturing the quality control function and the quality management system, including the following tasks:
* Performing periodic internal quality control system reviews and audits
* Designing, developing, implementing and enforcing best practices, processes, guidelines, systems, and technology to support and enhance the quality control function and the quality management system.
* Analyzing performance of quality control function and quality management system activities and documented resolutions, identifying problem areas, and devising and delivering solutions to enhance quality control and prevent future issues.
* Represent quality control function and related processes in connection with internal or external audits, inspections, monitoring visits and new business development activities, and assist with 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 control function and the quality management system remain in compliance with applicable regulatory and corporate standards/requirements and current with industry trends and best practices.
* Support strategic planning by timely communicating Quality deliverables, constraints, risks and options, and collaborating with Technical Development, Program management, Clinical, Commercial, Supply Chain, and internal and external Manufacturing teams.
* 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 (Chemistry, Biological sciences, Engineering or related degree); advanced degree is a plus.
* Minimum of 10 years related experience in the Pharmaceutical/Biopharmaceutical/Biotechnology industry.
* Ideally a minimum of 8 years of experience in leading Analytical Development/Quality Control function, preferably at the Director level.
* Proven ability to effectively develop, communicate, and gain support for execution plans and strategies with a wide range of stakeholders.
* Leadership and management skills to grow and manage a high performing Quality organization.
* Demonstrated skills in project management and working with vendors and contractors
* Expert background in FDA, ISO, EMA, GMP and ICH requirements ideally for ATMPs.
* Proven experience with regulatory submissions, ideally for products which were ultimately approved for commercial distribution, and regulatory inspections.
* Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills, excellent 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.
* Must be available to work in the evenings and weekends, as required.
Position Location and/or Territory and Travel
* Position is located in the United States - Irvine, CA or Boston, MA.
* Position may require up to 30% travel (or) 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.