Senior Manager Quality Operations

Charles River Laboratories • Rockville, MD

116d • $140,000 - $160,000

About The Position

The Senior Manager Quality Operations is responsible for partnering with functional stakeholders at the site level to ensure Quality performance and Compliance is designed into, and maintained, across all strategic initiatives, Operations, functional support organizations, and execution of GMP activities at the Rockville site. The candidate filling this role is responsible to oversee execution and delivery from the following areas of the organization: Functional Organization Quality Oversight, On the Floor Quality, QC testing for in-process, stability, and release as well as customer facing Quality program leads for each client in the CDMO-Rockville portfolio. The person filling this role will be responsible for the leadership, development and training of team members within their oversight as well as providing supportive leadership and strategic direction to operate with and maintain compliance to regulatory and industry quality standards in support of existing and new cell-based gene therapy production.

Requirements

• BS required; MS preferred in scientific/technical discipline.
• Minimum of 5 years of experience in a Quality department leadership role within the biological and/or pharmaceutical industry.
• Experience preferred with CDMO business and/or gene-modification modalities, cell-based gene therapies.
• Experience in reviewing quality control test reports and batch production records clinical and commercial pharmaceutical/ biopharmaceutical manufacturing.
• Excellent working knowledge and experience with the practical implementation of FDA, EMA and ICH regulations and guidelines.
• Experience in TrackWise is preferable.
• Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges with poise, tact, and diplomacy.
• Exceptional verbal and written communication skills to all organization levels and clients.
• Strong organizational skills; able to prioritize and manage through complex processes/projects.
• Ability to define problems, collect data, and draw valid conclusions.
• Extensive experience with writing and managing investigations and risk assessments.
• Previous experience as an auditor for internal and vendor audits.
• Ability to be hands-on and detail oriented.

Responsibilities

• Provides the necessary leadership for creating a culture of Quality and Compliance that is well integrated and supportive of end-to-end supply.
• Works with project teams and individual departmental staff to provide guidance and strong quality leadership.
• Manages and schedules Quality Assurance personnel for support of CGMP operations.
• Ensures only trained and experienced employees are involved in authoring and reviewing a controlled document.
• Ensures current Good Manufacturing Practices (CGMPs) compliance for manufacturing of biological product, and compliance to 21 CFR Parts 210, 211 and 600 as applicable.
• Monitors projects and helps to resolve issues or escalate appropriately to ensure on time delivery of all client projects with management of effective risk mitigation plans and stakeholder communication.
• Collaborates with full range of personnel in manufacturing and technical work teams that support Fill/Finish to identify root cause of a problem and determine appropriate corrective action and preventive action for investigations.
• Manages the review (audit) of batch production records, EM test reports, cleaning records, material release documentation and quality control test reports, prepare BPR audit reports and follow-up with task owners for the completion of the identified deficiencies.
• Ensures that QA batch record review and lot release deliverables are client focused, results oriented, performance driven, and in compliance with all applicable internal and external requirements.
• Responsible for lot disposition and release of products.
• Reviews and approves batch production and development records in support of GMP regulated operations.
• Reviews and approves ancillary facility and equipment records in support of GMP regulated operations.
• Reviews and approves assay qualification, equipment, and stability protocols and reports.
• Provides technical expertise in conducting investigations and making recommendations for targeted data and information collection as required for quality events.
• Contributes to data and information collection.
• Alerts management of critical issues that have significant impact to manufacturing objectives and timelines, while providing a range of achievable solutions.
• Manages the walkthrough program in GMP Manufacturing, quality control testing, storage and material receiving area for compliance to approved procedure.
• Oversees the revision, issuance and tracking of controlled documents used to support the bulk and sterile fill biologic products.
• Additional duties as assigned, including a willingness to cross-train and support in other functional Quality areas such as Quality Systems, Training, Document Control, and Supplier Quality.

Benefits

• bonus/incentives based on performance
• 401K
• paid time off
• stock purchase program
• Health and wellness coverage
• employee and family wellbeing support programs
• work life balance flexibility

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree