Senior Manager, Quality Assurance

Mallinckrodt Pharmaceuticals•Cranbury, NJ

2d•$151,000 - $241,000•Onsite

About The Position

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.

Requirements

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.
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 deviations, CAPA, change control, risk management, training, complaints, and audit management.
Knowledge of biologics, pharmaceutical, biotechnology, and/or combination product manufacturing processes.
Understanding of regulatory inspection practices and requirements, including FDA and other global regulatory agency expectations.
Familiarity with data integrity requirements and industry best practices.
Ability to influence, collaborate, and build effective partnerships across Quality, Manufacturing, Regulatory Affairs, Supply Chain, and Technical Operations.
Strong communication and interpersonal skills, with the ability to effectively interact with all levels of the organization, external partners, auditors, and regulatory agencies.
Demonstrated ability to manage multiple priorities and drive results in a fast-paced, regulated environment.
Strong analytical, critical thinking, decision-making, and problem-solving skills.
Effective project management and organizational skills with the ability to lead complex quality initiatives.
Strong technical writing and documentation review skills.
Ability to lead investigations, perform risk assessments, and drive continuous improvement initiatives.
Demonstrated leadership presence with the ability to influence decisions, manage change, and achieve business objectives through collaboration and negotiation.

Nice To Haves

Knowledge of aseptic processing, environmental monitoring, and contamination control principles preferred.

Responsibilities

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.
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.
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.
Leads and contributes to the development, management, harmonization and improvement of quality systems 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.
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.