Senior Manager, Quality Assurance

Mallinckrodt; Cranbury Township (NJ); Sur place; USD 140 000 - 180 000; Plein temps

Résumé du poste

Mallinckrodt seeks a Senior Manager, Quality Assurance to lead Quality Operations and Quality Systems at the Cranbury, NJ and Rye, NY facilities, ensuring compliance with cGMP, FDA regulations, and international quality standards.

You will drive batch release, material disposition, CAPAs, deviation investigations, and inspection readiness, while mentoring a team and maintaining the Quality Management System across multiple sites.

Qualifications

• Bachelor's degree in a scientific/engineering field required; advanced degree preferred.
• 8+ years of progressive experience in Quality Assurance, Compliance, and Quality Systems.
• Biologics, Biotechnology, and Pharmaceutical/Biopharmaceutical experience.
• 3–5 years of people leadership experience.
• Experience with terminally sterilized and/or aseptic operations.
• cGMP compliance experience; implementation a plus.

Responsabilités

• Provide leadership and oversight for Quality Operations on manufacturing floor, line clearance, sampling, material disposition and batch release.
• Review and approve raw materials, in-process materials, and finished product batches for cGMP compliance.
• Lead deviation investigations, root cause analyses, CAPAs, and effectiveness monitoring.
• Lead or support regulatory inspections, customer audits, and internal audits while ensuring inspection readiness.
• Maintain the Quality Management System and ongoing quality compliance training initiatives.

Connaissances

Quality Leadership

Regulatory Knowledge

cGMP awareness

Formation

Bachelor's degree in a scientific/engineering discipline

Advanced degree preferred

Description du poste

Job Title

Senior Manager, Quality Assurance

Requisition

JR000016014 Senior Manager, Quality Assurance (Open)

Location

US NJ Cranbury

Job Description Summary

The Senior Manager, Quality Assurance is responsible for the direct oversight, management, and execution of Quality Operations and Quality Systems activities at the Cranbury, NJ, and Rye, NY facilities, ensuring compliance with current Good Manufacturing Practices (cGMP), FDA regulations, applicable international quality standards, and company policies and procedures.

Provides leadership, oversight, and direction for Quality Operations and Quality Systems including manufacturing floor operations, incoming material inspection, raw material disposition, in-process quality review, and finished batch release. Ensures the effectiveness and compliance of quality processes supporting facilities, equipment, utilities, materials, production, laboratory, packaging and labeling, distribution, and other GxP regulated operations. Accountable for maintaining compliance with applicable FDA regulations, current Good Manufacturing Practices (cGMP), Quality System Regulations (QSR), applicable ISO standards, and global regulatory requirements. Leads inspection readiness efforts, supports regulatory inspections. Serves as the designated backup to the Site Director of Quality.

Cranbury, NJ and Rye, NY Quality Assurance

Job Description

Quality Operations

Provides leadership and oversight for Quality Operations for quality floor operations which include but are not limited to manufacturing floor quality support, line clearance activities, product sampling, incoming material inspection, material disposition, and batch release activities. line

Oversees the review and approval of raw materials, in-process materials, and finished product batches to ensure compliance with cGMP requirements and internal quality standards.

Reviews and approves product stability data and supports stability program management.

Directs batch record review and batch data review activities to ensure product quality and regulatory compliance.

Reviews and approves product stability data and

Develops, implements, and maintains Quality Assurance procedures, policies, and processes to support compliant operations and continuous improvement.

Provides oversight of the site's environmental monitoring program which includes routine monitoring, annual requalification activities, and post-maintenance requalification of manufacturing rooms and other classified plant areas.

Manages Quality Assurance owned equipment and ensures appropriate calibration, preventative maintenance, and life cycle management activities are completed in accordance with established procedures.

Compliance & Management

Leads and contributes to the development, management, harmonization and improvement of quality system and procedures to ensure compliance with all applicable laws, regulations and company quality standards in support of cGxP activities.

Leads deviation investigations, root cause analyses, corrective and preventive actions (CAPAs), and effectiveness monitoring in the Quality and Manufacturing areas.

Leads non-conforming material investigations and product quality issues.

Reviews and approves OOS/Laboratory investigations

Lead or support regulatory inspections, customer audits, and internal audits while ensuring inspection readiness.

Responsible for the maintenance of the Quality Management System and ongoing effectiveness and compliance.

Manages Quality Agreements with contract manufacturers, suppliers, vendors, and business partners.

Responsible for plant Risk assessment programs.

Responsible and ensures the effectiveness of the site's GxP training program and quality compliance training initiatives.

Product Quality Review & Regulatory Support

Oversees and contribute to the preparation and approval for Annual Product Reviews/Product Quality Reviews

Reviews and approves updates for regulatory filing(s), as applicable.

Prepares, reviews, and approves controlled documents relevant to GxP operations.

Develops quality metrics and reports for site leadership and management review.

Education & Experience

Bachelor's degree in a scientific, engineering, or related technical discipline required; advanced degree preferred.

Must have a minimum of 8+ years of progressive experience in Quality Assurance, Compliance, and Quality Systems within the pharmaceutical industry.

Must have previous Biologics, Biotechnology, and Pharmaceutical or Biopharmaceutical experience.

Must have at least 3-5 years of people leadership experience.

Industry experience with or knowledge of terminally sterilized and/or aseptic operations is required.

Experience in maintaining cGMP compliance a must; implementing a plus.

Knowledge

Strong knowledge of current Good Manufacturing Practices (cGMP), applicable FDA regulations, ICH guidelines, and quality systems requirements.

Working knowledge of Quality Management Systems (QMS), including