Overview

The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, QC data, SOPs, material releases and final product releases as well as assists Quality management with department needs.

The ideal candidate in this role, the Manager, Quality Assurance exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Implements ongoing quality improvement processes working with interdepartmental teams. Develop and manage quality assurance metrics for performance improvement of all teams. Anticipates program release problems and takes corrective action, escalating as needed, to resolve and achieve commitments. Works with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment, customer integration, and professional services validation.

Essential Functions and Responsibilities

Ensure the safe release of cellular products in accordance with company and/or client procedures and requirements.
Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs
Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues.
Establish and maintain policy for documentation of all products and perform internal documentation audits.
Author and review relevant SOPs, validation and other documents.
Ensure timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports.
Ensure the completion of all client requirements related to cellular product and/or material releases, including documentation review.
Control Master Batch Records, distribution and label verification
Perform line clearance activities as required.
Assign and maintain product lot numbers as applicable.
Ensure materials management nonconformance disposition and release activity as applicable.
Ensure accurate deviation reporting as applicable and tracking/trending follow up actions to closures
Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions.
Provide Quality Assurance related support to various departments.
Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies.
Monitor and maintain the corrective action process which included driving and coordination of the investigation, root cause analysis, action plan, and effectiveness checks.
Provide support to manufacturing for investigations of deviations, validations, and development of specifications
Provides metrics for quality management reporting and helps to identify areas for further monitoring for improvements.
Effectively host client audits and provide on time response to audit findings as well as facilitate completion of corrective actions noted.
Perform employee training on QSR and ISO requirements and company quality systems
Perform document control activities as assigned.
Mentor/train/develop and manage Quality Assurance team.
Lead the implementation of Quality Agreements with Clients and maintain compliance to Quality Agreements

Qualifications

Minimum 5-10 years related experience in the pharmaceutical or biologics industry.
BS Degree in biological sciences or equivalent.
Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs).
Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc.
Sound knowledge of aseptic processing and supporting technologies.
Analytical and technical troubleshooting skills are a plus.
Proficient with Microsoft Office Suite
Excellent organizational skills and attention to detail.
Good verbal and written communication skills.
Strong team-oriented interpersonal skills are essential.
Travel may be required

Competencies/Candidate Profile

Strong business acumen
Relevant IT skills (able to work with Visio, Microsoft Project and Excel)
Ability to think strategically and tactically (detail-oriented)
Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment
Analytical and problem-solving skills
Strong written and oral communication skills
Meeting management/facilitation skills/teamwork
Ability to multi-task is essential
Flexible and able to adapt to company growth and evolving responsibilities