Associate Director, Quality Systems And Compliance (qs&c)

The Associate Director QS&C should be detail oriented and will have responsibility for planning, designing, development, implementing, maintaining, continual improvement, and performing a variety of tasks related to training, vendor management, and audit program systems and compliance programs supporting GxP activities.  This position requires experience working in GxP regulated environments and practical knowledge in FDA and applicable international regulatory requirements and interactions with Clinical Operations, Pharmaceutical Operations, Program and CMC Project Management, Regulatory Affairs, Supply Chain, and CMOs, to achieve sustainable compliance in GxP operations.    

Primary Responsibilities:

• Planning, designing, development, implementing, maintaining, and continual improvement of training, vendor management, and audit program systems policies, standard operating procedures (SOPs), and applicable supporting documentations (e.g. Forms, Templates, Work Instructions, etc.) ensuring regulatory and internal compliance.
• Provides support for the Quality oversight of IT systems used to support training, vendor management, and audit program systems.
• Maintain current knowledge base of regulations, corporate policies, and standards to ensure that the QS&C function and the quality management system remain in compliance with applicable regulatory and corporate standards/requirements and current with industry trends and best practices.
• Support strategic planning by timely communicating Quality deliverables, constraints, risks and options, and collaborating with Technical Development, Program management, Clinical, Commercial, Supply Chain, and internal and external Manufacturing teams.
• Design, develop, implement, maintain, and continually assess quality management system for the training, vendor management, and audit program and applicable regulated activities to meet internal company standards and external regulatory and customer requirements, including but not limited to, the following tasks:
  • Development and implementation of appropriate training program
    • Work with functional heads to develop user roles, learner roles, and curricula via set up of user roles and learning accounts for on-boarding new users as well as off-boarding of applicable personnel using the integrated electronic learning management system.
    • Create and deliver applicable annual GxP refresher training, GxP document content classroom training, train-the-trainer training, and where applicable on-the job training.
    • Establish applicable automatic/configurable training metrics report dashboards using available data from the electronic learning management system for delivery to applicable functional heads that can be used to monitor the effectiveness of processes within the training program and functional area training status.
    • In coordination with functional heads, establish a process for uploading and maintenance of other training medium (e.g. recorded training, presentations, courses, workbooks, training manuals, exercises or activities, etc.) where training is required.
    • Develop system for the uploading of legacy or training completed outside of the electronic learning management system.
  • Vendor and Audit Management
    • Partners with cross functional department heads/functional area Subject Matter Experts (SMEs)/Vendor Owner/stakeholders for any QA vendor assessments of the suitability and competence of the other party prior to outsourcing operations or selecting material vendors, to carry out the activity or provide the material using Keros vendor management and audit program systems policies, standard operating procedures (SOPs), and supporting documentations (e.g. Forms, Templates, Work Instructions, etc.) (e.g., audits, material evaluations, qualification).
    • Establish applicable vendor key performance indicator using available data that can be used to monitor vendor performance and establishment of risk-based audit program.
    • Responsible for vendor lifecycle from qualification to retirement including audit planning, preparation, performance, reporting, observation/finding response assessment, and audit closure in collaboration with all applicable SMEs whether performed by internal or external contracted auditors.
    • Develop and maintain Approved Vendor List, Audit Plan, and vendor files that include all records resulting from documented evidence of evaluations and/or assessments.
  • Identify risks and assumptions in plans, anticipate problems and plan for contingencies.
  • Remove obstacles to move work forward and/or to get efforts back on track.
  • Operates to the highest ethical and moral standards.
  • Complies with company’s policies and procedures.
  • Adheres to quality standards set by regulations and company's policies, procedures and mission.
  • Communicates effectively with supervisors, colleagues and subordinates.
  • Ability to participate effectively as a team player in all aspects of company's business.
  • Demonstrate administrative leadership with knowledge-based expertise in related areas that can be applied to meeting company's strategic goals.
  • Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices.
  • Performs other related duties as assigned.

Qualifications:

Basic Qualifications

• Bachelor's Degree is required (Biological sciences, Engineering, or related degree)
• Minimum of 10 years related experience in the Pharmaceutical/Biopharmaceutical/Biotechnology industry.
• Ideally a minimum of 8 years of experience in leading a Quality function, preferably at the Senior Manager or Associate Director level.
• Experience with implementation of Quality Management Systems preferably in training, vendor management, and audit program systems and compliance programs supporting GxP activities.
• Proven ability to effectively develop, communicate, and gain support for execution plans and strategies with a wide range of stakeholders.
• Leadership and management skills to grow and manage a high performing Quality organization.
• Demonstrated skills in project management and working with vendors and contractors.
• Expert background in FDA, ISO, EMA, GMP and ICH requirements ideally for advanced therapy medicinal products.
• Proven experience with regulatory submissions, ideally for products which were ultimately approved for commercial distribution, and regulatory inspections.
• Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills, excellent interpersonal skills, organizational skills, written and oral communication skills.
• Ability to work in a fast paced and dynamic environment that will require management of several competing priorities while driving all projects forward and meeting program/project deliverables.
• Energetic, flexible, collaborative and proactive; a leader who can positively and productively impact initiatives.
• Position may require up to 20% travel.

Preferred Qualifications

• ASQ Certified Quality Auditor is a plus including experience in the performance of international and/or domestic virtual, on-site, or desk audit.
• Demonstrates a thorough knowledge of GxP regulations and guidelines.
• Excellent written and oral communication skills and interpersonal skills.
• Ability to effectively manage multiple projects.
• Must be proficient in Microsoft Office applications, DocuSign, ComplianceWire, and Veeva Vault Quality Docs and Management Systems.

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