Senior Manager, Quality Operations

The Sr. 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 extensive 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.

• Following policies and standard operating procedures (SOPs) relating to the Quality Operations function. Identify opportunities for improvements and secure consensus of the stakeholders.

• Conduct quality review of manufacturing documents for batch disposition and product life cycle management:

• Master and executed Batch Records

• Quality reports

• Technology transfer protocols and reports

• Specifications

• Deviations

• Change Controls

• CAPAs

• Batch certificates.

• Assure that Deviations and Change Controls at the CMO sites are thorough and cGMP compliant and resolved in timely manner.

• Assist in Developing and executing appropriate quality training for the team.

• Assure accuracy and completeness of all required documentation necessary in support for 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.

• Assist the development Keros QMS; author, review and approve Quality SOPs and job aids.

• Assist as needed during regulatory inspections at the CMO sites.

• Participate in developing and implementing short-term and long-term strategies, goals, objectives, and tactics relating to the Quality Operations function.

• Review and recommend appropriate corrective action to ensure consistency with the Quality Operations function.

• Assist with internal or external audits, inspections, monitoring visits and new business development activities, and provide (when requested) 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.

• Any additional duties assigned by supervisor.

General Responsibilities

• 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.

• Operates to the highest ethical and moral standards.

• Complies with company's policies and procedures.

• Adheres to quality standards set by regulations and company's policies, procedures, and mission.

• Communicates effectively with supervisors, colleagues, and subordinates.

• Ability to participate effectively as a team player in all aspects of company's business.

• Demonstrate administrative leadership with knowledge-based expertise in related areas that can be applied to meeting company's strategic goals.

• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices.

• Performs other related duties as assigned.

Basic Qualifications

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

• Minimum of 6-8 years related experience in the Pharmaceutical/Biopharmaceutical/Biotechnology industry.

• Ideally a minimum of 5-7 years of experience in Quality function, preferably at the supervisory level.

• Proven ability to effectively work, communicate, and gain support with team members from other functions.

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

• Demonstrated skills in project management and working with vendors and contractors.

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

• Familiar with regulatory submissions,

• 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 and empower team.

Preferred Qualifications

• ASQ Certified Quality Auditor is a plus including experience in the performance of international and/or domestic virtual, on-site, or desk audit.

• Demonstrates a thorough knowledge of GxP regulations and guidelines.

• Excellent written and oral communication skills and interpersonal skills.

• Ability to effectively manage multiple projects.

• Must be proficient in Microsoft Office applications, DocuSign, ComplianceWire, and Veeva Vault Quality Docs and Management Systems.

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