Product Quality Manager

Katalyst-Healthcares-; City of Rochester (NY); On-site; USD 120,000 - 180,000; Full time

Job summary

Creative Solutions Services, LLC in New York is seeking an experienced Quality Assurance leader to oversee aseptic manufacturing operations, ensuring regulatory compliance and driving on-time, high-value quality deliverables across TPM and client teams.

The role focuses on audit readiness, CAPA management, and close collaboration with third-party manufacturers to sustain product quality and regulatory approvals.

Qualifications

• Bachelor's degree in Life Science or equivalent; required.
• 7+ years total experience; 5+ in QA/aseptic ops; 3+ in related roles.
• Knowledge of aseptic manufacturing and related pharmaceutical technologies.

Responsibilities

• Maintains the primary quality lead with management oversight for project activities and the team members to achieve on-time quality deliverables.
• Drives quality and compliance for product transfers and organization optimization.
• Provides QA TPM team support for aseptic event investigations with hands-on assessments.
• Drives implementation of aseptic best practices at TPM per Client standards.
• Performs final quality release of manufactured product lots for Third Party Manufacturers.

Skills

Quality Assurance Leadership

Aseptic Manufacturing

Regulatory Compliance

Project Oversight

Education

Bachelor's Degree in Life Science or equivalent

Tools

Quality Systems

Job description

Responsibilities:

• Maintains the primary quality lead with management oversight for project activities and the team members (within and outside of Client) to achieve on-time quality deliverables, high customer value, and profitable results.


• Primary driver for the quality and compliance aspects of product transfers and organization optimization.


• Provides Eye Care Quality Assurance Third Party Manufactures (TPM) team support for investigation for aseptic events by providing hands-on assessments and investigation support.


• Drives implementation and aseptic best practices at TPM based on Client's standards and technological advancements.


• Performs final quality release of manufactured product lots for products and/or product lines prepared by Third Party Manufacturers.


• Makes recommendations for key decisions on product quality and compliance and regulatory conformance issues for sterile, biological, liquid, solids, and/or device products and elevates medium and high risk events to Client management.


• Ensures alignment of Quality and Technical Agreements with the legal contracts and that the commitments of the quality and technical agreements are being fulfilled. Helps facilitate resolution in cases where they are not.


• Establishes and maintains relationships and open communication with Third Party Manufacturers, Client plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs at each site and provide guidance on quality concerns.


• Communicates and negotiates with external companies' quality organization to maintain a consistent level of quality and a level of expectation that will minimize compliance risks but also balance the cost of operating to provide Client with the agreed service. Prioritizes programs, initiatives, and problem solving with consideration for impact to timelines, resources and conflicting priorities.


• Interfaces with Quality Assurance audit team to develop audit plans, due diligence plans, and inspection readiness plans, review audit observations and responses, and maintain corrective action timetable. Provides support for quality audits, initial site approvals and due diligence activities. Leads and manages pre-approval inspection readiness as related to the third party manufacturers to ensure regulatory approvals are obtained, with no delays to market entries.


• Contributes to Quality Assurance elements needed to facilitate new product launches including Third Party Manufacturer's that provide products directly to distribution centers, or to Client domestic and International plants for further packaging and/or testing.


• Coordinates activities to support follow-up on compliant trend investigations for non-medical and medical (adverse events). Supports the management of exception documents and Corrective and Preventive Actions.


• Completes management reviews with assigned Third Party Manufacturers that identify and address quality, operational, and organizational issues.


• Obtains and reviews summaries of the Annual Product Reviews (domestic) and Annual Product Quality Reports (EU) from the Third Party Manufacturer to ensure accuracy, completeness, timeliness, and trends are identified and addressed in an appropriate manner.

Qualifications:

• Bachelor's Degree in relevant Life Science or other technical discipline or equivalent job experience required.


• 7+ years of total combined experience. At least 5 years in Quality Assurance/Aseptic Manufacturing Operations Management; 3 years in Operations, Research and Development or Consulting.


• Knowledge and comprehensive understanding of aseptic manufacturing and some biological and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solid tablets and caplets, suspensions, granulations, soft elastic capsules, gel caps, extended release products, coating solutions, and/or active pharmaceutical ingredients).


• Possesses knowledge and a skill set to operate within an environment that requires a high degree of urgency, strong analytical and problem solving skills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as leaders, members and individuals.