Manager, Quality Assurance & Compliance

Summary

The Manager, Quality Assurance & Compliance is responsible for leading and managing the Quality Assurance and Compliance team and activities, management of the internal/external audit programs, Supplier Quality Management, Annual Product Review, Quality Agreements, management of the batch record pre and post review process and resolution of customer quality issues including NCRs, Complaints, CAPAs etc.

The incumbent is responsible for contact with internal stakeholders and external customers regarding quality issues related to documentation, inspection, receiving, manufacturing/packaging and distribution processes. This role will serve as a subject matter expert and will ensure that the QA and Compliance team is trained and operates in compliance with applicable SOPs, internal processes and regulations.

Essential Duties And Responsibilities

• Provide leadership, guidance and direction for the Quality Assurance and Compliance team.
• Oversee the key quality processes that impact/relate to product compliance including batch record review and product release, compliance in movement and storage of materials, Investigations, and CAPAs as related to product compliance.
• Develop and implement quality assurance policies and procedures.
• Track, monitor and analyze key performance indicators (KPIs). Present KPIs to appropriate members of site leadership on a regular basis.
• Responsible for the management of the batch record pre and post review processes including providing oversight of master batch record issuance and batch release processes for Manufacturing and Packaging.
• Responsible for negotiation and approval of customer Quality and Technical agreements.
• Responsible for providing continuous oversight and management of Supplier/Vendor Quality Management programs, audit programs and Annual Product Reviews (APRs) to assure compliance with company policies, cGxPs and other applicable regulatory requirements.
• Provide guidance and assist in appropriate problem-solving initiatives to address customer or regulatory quality issues.
• Ensure processes needed for the Quality Management System are documented and are effective.
• Lead the Quality Management Review processes at the site.
• Ensure the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization through training, learning and development programs.
• Troubleshoot and direct the resolution of Quality issues related to Packaging and Manufacturing by fostering effective interdepartmental and cross-functional partnerships.
• Develop and maintain KPIs for batch record review right first time and error tracking.
• Provide guidance and mentorship to team members to enable opportunities for professional development and growth.
• Lead process improvement initiatives related to Quality Assurance.
• Oversee the clinical label release and issuance processes to ensure that quality and compliance standards are met.
• Provide input to the development of personal performance goals and departmental objectives.
• Apply advanced theory, technical principles, and expert judgment to address a broad range of issues affecting product compliance.
• Serve as a technical subject matter expert (SME) in support of department functions.
• Train personnel and internal customers on relevant business processes.
• Review and approve documents, such as Change Orders, Investigations, Deviation Reports, Manufacturing Instructions, Out of Specification test results, and Component Specification Sheets to ensure quality and compliance standards are met.
  
  

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Bachelor’s Degree in a science or technical field
• Master’s Degree in a science or technical field, preferred but not required.
• A minimum of 8 years’ experience in a regulated pharmaceutical or biopharmaceutical industry.
• Leadership experience in Quality Assurance or Quality Operations required, including a demonstrated ability to identify problems, investigate and perform or guide the team with Root Cause Analysis and initiate successful CAPAs.
• Quality Assurance experience in a Clinical or Commercial environment with demonstrated knowledge of techniques for assessing the quality of processes and the ability to guide others in these activities.
• Advanced knowledge of cGxPs, ISO and other applicable regulatory requirements for pharmaceuticals and medical devices and the ability to communicate this knowledge to the entire organization professionally and succinctly.
• Strong understanding of and experience supporting functional areas of business, including but not limited to, accounting and budgeting, manufacturing, materials management, laboratory operations, and workforce planning.
• Must demonstrate excellent interpersonal, writing and communication skills as well as ability to liaise and interface with cross-functional teams.
• Ability to organize and prioritize work to meet targeted timelines.
• Must have the ability to adapt to different technologies, work styles, and communication methods, especially as the business, tools and processes evolve.
• Experience with Microsoft Office applications, eQMS and ERP systems.
• Has adequate emotional intelligence to handle a variety of situations professionally and in accordance with regulatory compliance expectations.
• Effective communication, organization, planning, initiative, follow-through, and responsiveness skills are required.