Senior Quality Specialist – Contract Manufacturing

Description

Job Purpose: 

The Senior Quality Specialist – Contract Manufacturing is responsible for providing quality oversight, project coordination, and regulatory compliance support for contract manufacturing organization (CMO) activities. This position serves as a primary liaison between internal departments, external customers, and contract manufacturing partners to ensure products and processes meet established quality standards, customer expectations, and applicable regulatory requirements.

The Senior Quality Specialist coordinates cross-functional activities related to new product introductions, product changes, manufacturing campaigns, quality investigations, customer complaints, change controls, and product lot releases. This role collaborates with Product Development, Production, Quality Assurance, Quality Control, Microbiology, Chemistry, and other relevant departments to ensure projects are completed accurately, efficiently, and within established timelines.

The position also supports customer audits, regulatory inspections, continuous improvement initiatives, and the effective execution of quality system processes related to contract manufacturing.

Essential Duties and Responsibilities:

• Ensure contract manufacturing products, processes, and activities comply with company quality standards, applicable cGMP requirements, regulatory  expectations, and customer quality agreements.
• Provide quality oversight and coordination for contract manufacturing initiatives, manufacturing campaigns, new product introductions, and special projects.
• Serve as a liaison between internal departments, external customers, contract manufacturing partners, and other stakeholders to support quality and operational objectives.
• Establish and maintain positive customer relationships by communicating quality performance, addressing concerns, coordinating resolutions, and providing timely updates.
• Communicate quality-related observations, discrepancies, risks, and potential violations of company policies or procedures to Executive Quality Management, as appropriate.
• Support the resolution of product, equipment, process, and manufacturing-related quality issues in collaboration with subject matter experts (SMEs).
• Develop, execute, and monitor project work plans in accordance with contract manufacturing requirements, quality system procedures, and business objectives.
• Establish project objectives, define deliverables, identify required resources, assign responsibilities, and develop realistic timelines and completion dates.
• Coordinate cross-functional activities to ensure project milestones, manufacturing requirements, and customer commitments are achieved.
• Provide project status updates, identify potential risks and delays, and communicate progress to the relevant stakeholders.
• Drive and coordinate CMO-related quality system activities, including change controls, deviations, investigations, corrective and preventive actions (CAPA), and material-related quality events, as applicable.
• Drive and coordinate CMO-related quality system activities, including change controls, deviations, investigations, corrective and preventive actions (CAPA), and material-related quality events, as applicable.
• Collaborate with the Quality Investigations team and other departments to support timely investigations, root cause assessments, and implementation of appropriate corrective actions.
• Coordinate troubleshooting activities involving equipment, manufacturing processes, laboratory testing, and product quality concerns.
• Initiate, coordinate, and monitor projects managed through the company's Quality Management System (QMS), including change controls, quality investigations, and material management activities related to contract manufacturing.
• Receive, coordinate, and support the investigation and resolution of customer complaints related to contract manufacturing products.
• Facilitate communication between customers and internal departments regarding product quality issues, investigation findings, corrective actions, and complaint resolution.
• Support the preparation, review, and organization of audit documentation and responses to customer quality inquiries.
• Support the preparation, review, and organization of audit documentation and responses to customer quality inquiries.
• Participate in regulatory inspections, audit preparation, and follow-up activities as required.
• Collaborate with SMEs and cross-functional teams to ensure accurate, consistent, and timely responses to external stakeholders.
• Coordinate activities among contributing departments to support the timely release of contract manufacturing product lots, including NPC product lots, in accordance with established quality requirements.
• Monitor product release milestones and communicate potential delays, outstanding requirements, and quality-related risks to appropriate stakeholders.
• Coordinate with Microbiology and Chemistry laboratories regarding testing status, anticipated delays, investigations, and other issues that may affect product disposition or release timelines.
• Facilitate cross-functional communication to resolve outstanding documentation, testing, investigation, and approval requirements affecting product      release.
• Support on-time product release while ensuring that all applicable quality and compliance requirements are met.
• Identify opportunities to improve processes, documentation practices, communication, project execution, and operational efficiency.
• Promote a culture of accountability, teamwork, integrity, continuous improvement, and regulatory compliance.

Requirements

Knowledge & Skills: 

• Strong knowledge of pharmaceutical quality assurance principles, cGMP requirements, and applicable FDA regulations.
• Working knowledge of 21 CFR Parts 11, 210, and 211; knowledge of 21 CFR Part 820 and other applicable quality regulations is      desirable, as relevant to assigned responsibilities.
• Strong project management, planning, organizational, and coordination skills.
• Excellent written, verbal, interpersonal, and technical communication skills.
• Demonstrated ability to coordinate cross-functional teams and manage multiple projects and priorities simultaneously.
• Strong attention to detail and the ability to review technical documents for accuracy, completeness, consistency, and      compliance.
• Ability to identify risks, investigate quality issues, support root cause analysis, and coordinate appropriate corrective actions.
• Ability to work independently with minimal supervision while maintaining accountability for assigned responsibilities.
• Strong customer service and relationship management skills, including the ability to communicate effectively with internal and      external stakeholders.
• Ability to adapt to changing business priorities and maintain effectiveness under pressure.
• Strong decision-making, problem-solving, and continuous improvement capabilities.
• Ability to maintain accurate, current, and well-organized records and project information.
• Demonstrated commitment to teamwork, integrity, professional development, and regulatory compliance.

Education/Experience: 

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, Engineering, Life Sciences, or a related scientific or      technical discipline required.
• 3+ years of progressive experience in pharmaceutical manufacturing, quality, visual inspection, validation, technical      operations, or a related discipline, with significant experience in sterile injectable and/or ophthalmic manufacturing.
• Experience supporting contract manufacturing, customer quality relationships, product introductions, or pharmaceutical      product release activities is desirable.
• Working knowledge of cGMP requirements and applicable pharmaceutical quality regulations.
• Experience supporting regulatory inspections, customer audits, deviations, investigations, CAPA, change controls, and      other quality systems activities as a technical SME.
• Equivalent combination of education, technical expertise, and relevant pharmaceutical experience may be considered where      appropriate.

Working Conditions / Physical Requirements:

• Position requires lifting (up to 40lbs), vision (20/20), standing (10%), sitting (40%), walking (50%), talking, typing and hearing.
• Incumbents are required to wear specified protective equipment as necessary.