This position is responsible for scheduling and performing external audits, hosting customer audits, and maintaining a Supplier Qualification program. Audits will include GMP, GLP, GCP audits (internal/external), as well as due diligence audits. The External audit scope will consist of excipient/API/component suppliers, contract laboratories, computer software suppliers, contract manufacturers and CRO's. This position is directly responsible for ongoing management, maintenance and continuous improvement of these quality programs.
Summary of essential job functions
Perform GXP audits based on a defined audit plan within specific time constraints
Prepare all associated documentation including audit plans and audit reports under strict confidentiality
Provide guidance and support in the development of corrective actions based on GXP principles and current industry standards. Track and monitor audit responses and the implementation of corrective actions
Provide independent review, comprehension, and discussion of departmental and corporate policies and procedures with multiple levels of employees and Management.
Provide interpretation of complex regulations through research of current corporate and governmental expectations.
Facilitate opening and closing audit meetings with all levels of Management
Author and approve Quality Compliance procedures.
Continually monitor quality indicators for trends, tracks, and report metrics.
Routinely participates in continuous improvement initiatives; Observation Assessment Teams, Global Response Teams development, tracking and closure of CAPAs resulting from regulatory, GQA, Internal Audits and critical deviations.
Maintains Site Inspection Readiness Tool (SIRT).
Develops and provide training, as required for revised or new processes for QA including Inspection Readiness.
Maintain compliance requirements for established quality systems programs.
Complete analysis, identify issues and provide recommendations for compliance improvements.
Perform review of results to audit process or equipment compliance to FDA and GMP requirements.
Participate in determining objectives of significant projects or assignments.
Help remediate processes and systems in accordance with company standards and regulatory requirements.
Interact with project teams and applicable research groups as they impact the quality operation.
Minimum Educational/Experience requirements
Bachelor's Degree, along with a minimum of 8 years of experience in Quality Assurance in a GMP environment, preferably in the pharmaceutical and/or biologic industry
Must have had a minimum of 3 years of QA Audit experience, leading internal/supplier audits
Ideally the person who fills this role should be a Certified Auditor from the American Society for Quality (ASQ)
Advanced knowledge and experience in external agency regulations
Experience with Trackwise or equivalent system
Experience determining compliance trends
Must have effective project management skills
Experience training and/or leading others through audits
Experience working independently
Excellent computer systems and MS Office skills with working knowledge of computer relational databases.
Must have the ability to travel within the U.S., as well as internationally, to conduct audit
The ability to effectively build and maintain relationships within a highly matrix team in order to effectively negotiate and solve problems.
The ability to facilitate and generate the exchange of ideas to resolve problems, prioritize solutions, select optimal solutions and implement decisions.
The ability to organize, prioritize and deliver tasks & projects with a sense of urgency.
Effective communication skills, both verbal and written, with respect to internal and external communications
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Healthpoint Biotherapeutics, a Smith & Nephew Business, is an Equal Opportunity Employer.