Manager, QA Manufacturing Operations

Role Summary

Manager, QA Manufacturing Operations. Location: Devens, MA. Leads QA operations for pharmaceutical manufacturing, ensuring product quality, regulatory compliance, and continuous improvement. Manages QA staff, oversees SOP reviews and batch-related quality activities, and supports regulatory inspections.

Responsibilities

• Establish and communicates performance objectives for Quality Assurance staff that are consistent with the business' unit goals, Quality and Technical Operations objectives.
• Provide quality floor support of complex manufacturing issues.
• Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment enhances unit performance and integration across site departments.
• Hires, integrates and develops high quality talent, capable of delivering against the department's goals and objectives.
• Provides quality oversight of manufacturing activities on a day-to-day basis and provides oversight of the review and approval of minor changes to master batch recipe records.
• Performs review and approval of Quality, Manufacturing, and Material Specification SOPs and documents.
• Provides oversight to Quality walkthroughs for shutdown and inspections readiness activities and ensures program management is in compliance with site and corporate procedures.
• Contributes to and supports the site team which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products.
• Reviews, approves and provides guidance for quality master data. Responsibilities include updates to Drug Substance lot status in applicable quality systems.
• Directly participates in internal audits or reviews as well as global health authority inspections. May include representation on inspection response and CAPA teams.
• May provide Quality review and approval of investigation records and CAPA, records.
• Provides for strategic foresight to identify and implement changes to enhance long term goals of the department and drive continuous improvement.
• May act as delegate for QA Operations Manager for departmental meetings, projects and tasks.
• Supervises up to 6 employees overseeing quality floor support of manufacturing.

Qualifications

• A minimum of 8 years' experience in biopharmaceutical quality, with a minimum of 2 years of management responsibility and 2 years of quality and compliance functions is preferred.
• Knowledge of US and EU cGMP regulations and guidance.
• Knowledge of biotech bulk and finished product manufacturing, Drug Substance or Drug Product disposition and batch record review is highly desirable.
• Knowledge of electronic systems including SAP, LIMS, QMS, and electronic batch recording systems, and proficiency with Microsoft Office (Excel) is desirable.
• Strong background and demonstrated effectiveness in quality assurance operation and compliance of commercial biologics manufacturing with direct accountability for final product release.
• Knowledge and proven experience in FDA, EMA, or other regulatory authority.
• Knowledge in Operational Excellence and Continuous Improvement is desirable.
• Experience in building and growing an organization into a high-performance team.
• Demonstrated leadership, interpersonal, communication, and motivation skills.
• Excellent writing and oral communication skills are required.
• Previous work responsibility, which required a high degree of attention to detail.
• Well-practiced in exercising sound judgment in decision-making.
• Demonstrated multitasking and organization skills.
• Past experience where one was required to work in a team-based environment with a diverse group of people.

Education

• B.S. in science, engineering, biochemistry or related discipline, or its equivalent.

Skills

• Leadership, interpersonal, communication, and motivation skills.
• Excellent writing and oral communication skills.
• Sound judgment in decision-making.
• Multitasking and strong organizational skills.
• Ability to work in a team-based environment with a diverse group of people.