Manager Quality Assurance

R K Pharma - Pearl River, NY

Full-time - Mid Level

Pearl River, NY

Chemical Manufacturing

About the position

The Manager Quality Assurance is responsible for managing the development, establishment, and maintenance of Quality Systems, policies, processes, procedures, and controls. This role ensures that the performance and quality of cGMP documentation and records conform to established standards. The Manager will report directly to the Executive Vice President of Quality.

Responsibilities

• Manage organizational quality with established SOPs and processes (Deviations/Investigation, CAPA, Quality/Operational Risk Management, Change Control, Quality Metrics, Internal Audits, External Vendor Audits, and Inspection Readiness)
• Manage the Inspection Readiness Program and oversee the execution of regulatory audits and tracking of responses to ensure progress. Compiles all regulatory inspection observations/findings and monitor for signals and trends.
• Assist in the management and logistics of third-party inspection related activities.
• Manage the Internal and External Audit Schedules/Programs and oversee the execution of the remediation responses to ensure progress. Compiles all audit findings and monitor for signals and trends.
• Manage the Vendor Management System, which includes the vendor approval and qualification process, maintenance of the Approved Vendor List, and oversee the management for creation/response to vendor questionnaires.
• Oversee Quality Operations (incoming inspection, in-process testing).
• Drive consistent reporting of appropriate Quality Management System and other applicable metrics.
• Establish and monitor quality metrics for GMP related functional areas within the organization. Issue monthly reports. Escalates significant issues to executive management, as required.
• Identify quality issues/discrepancies, and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner.
• Promote a quality mindset within Quality and throughout RK Pharma by ensuring consistent, risk-based, and innovative thought processes are employed to advise and make decisions.
• Communicate milestones and planned changes to the user community regarding Quality System and Compliance initiatives.
• Provide operational management for the functional team.
• Train team members and/or coordinate training for the facility including but not limited to annual cGMP training.

Requirements

• In-depth knowledge of aseptic processing, isolator experience a plus.
• In depth knowledge of GxP regulations. Strong knowledge of good regulatory compliance practices, policies, and procedures.
• A strong customer focus and ability to prioritize and adapt to business needs are required.
• Excellent written and verbal communication skills including the ability to communicate and negotiate across the organization.
• Extensive knowledge of risk assessment strategies and tools. Ability to identify and mitigate risks.
• Extensive knowledge of investigation techniques and tools.
• Demonstrated ability to work across functions at all levels where the incumbent may not have direct authority to accomplish objectives.
• Ability to make independent sound decisions and independently manage priorities in alignment with customer and company objectives.
• Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
• Must be a dynamic, hands-on manager with a clear practical understanding of GXPs and the ability to support regulatory inspections, as required.
• Must be able to manage problems of diverse scope using a high degree of personal judgment and must be able to effectively represent RK Pharma.
• Ability to effectively mentor and develop staff.
• Problem-solver with the ability to make difficult decisions under challenging circumstances.
• Excellent knowledge of best practices in manufacturing, packaging, and quality systems.
• Excellent organizational skills.
• Technical knowledge of pharmaceutical manufacturing, validation, raw materials, analytical testing, and materials management.
• Prior experience with Master Control software is a plus.

Nice-to-haves

• Advanced scientific, technical, or business degree a plus.