Director Of Quality Assurance

Director of Quality Assurance

The Director of Quality Assurance is responsible for leading the planning, implementation, and on-going evaluation of Entrinsic Bioscience quality control programs and operating standards, for both our patented ingredients and finished products.

This person will contribute to our success by being highly knowledgeable of industry regulations, industry best practices for manufacturing and storage of products, as well as the design and implementation of quality systems.

The person in this role must be quality focused and have a strong understanding of hot-fill and aseptic beverage processing, different types of dietary supplement manufacturing and the associated quality systems.

They will be responsible for oversight of all quality operations and activities on a daily basis. In this capacity, the incumbent will inspect, approve and coach all third-party manufacturing, storage and logistics partners, to ensure EBS ingredients and products always maintain the highest standards. They will manage the testing, documentation and quality release of all production runs, and the database of batch records containing these results.

Additional responsibilities include representing the Quality Assurance function in all cross-functional and operational meetings, meetings with current and potential partners, and meetings with regulatory authorities.

The Director of Quality Assurance must be highly organized, have excellent communication skills and the demonstrated ability to manage all aspects of a Quality Assurance program.

Responsibilities:

• Develop and reports Key Performance Indicators to measure CMO and Labeler performance and for contribution to Management Review.
• Review and approve specifications, Contract Manufacturing Organization (CMO) upstream and downstream reports, change controls, stability protocols, and related documentation.
• 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.
• Facility Audit,
• Batch Record and Packaging Record Review
• Oversees vendor performance and delivery; identifies risks/deficiencies in current state vendor delivery.
• Process Review
• Maintain current knowledge base of FDA and EMA regulations, corporate policies and standards to ensure that the quality control 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.
• Create internal Certificates of Analysis for product release.
• Participate in regulatory inspections and audits, as needed.
• Act as subject matter expert for internal SOPs
• Review and Approve Deviations and CAPAs
• Drive vendors to seek innovative ways to improve delivery and quality Develops and reports Key Performance Indicators to measure CMO and Labeler performance.
• Documentation Review

Skills, Education and Experience:

• Experience interacting with and responding to US and other Health Authorities.
• A detail-oriented, yet agile multitasker who thrives on timelines, completeness and on-time delivery.
• 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.
• A root cause investigator, always looking for ways to improve and optimize.
• Minimum of 5 years related Quality Assurance experience in the Pharmaceutical/Biopharmaceutical/Biotechnology or Consumer Goods industry
• Demonstrated skills in project management and working with vendors and contractors.
• Excellent interpersonal skills, organizational skills, written and oral communication skills.
• Energetic, flexible, collaborative, proactive; can positively and productively impact initiatives.
• Ideally 5 years of experience in leading the Quality Assurance function, preferably at the Director/Senior Manager level.
• Proven ability to effectively communicate, and gain support for execution plans and strategies with a wide range of stakeholders.
• Solid experience working within US and EMA GMPs.
• A collaborator, who knows how to enlist external partners to achieve project objectives.
• Bachelor's Degree is required (Chemistry, Biological sciences, Engineering or related degree); advanced degree is a plus.
• Background in FDA, GMP, ICH and ISO requirements, ideally for Beverage, Supplement and Drug products.
• Experience with document preparation needed to support regulatory submissions and address regulatory inspections.
• Significant experience in the Hot-Fill and Aseptic Beverage industries, and ideally also Dietary Supplements.

Position will require up to 20% travel.