Director of Data Integrity
hace 2 meses
We are looking for a Director of Data Integrity to join our client in Guadalajara, Mexico. Our client has over 75 years of experience and is a commercial organization focused on the development, manufacturing and sterilization of complex medical device and pharmaceutical products.
**Responsibilities**
- Define and implement a data integrity governance program and provide strategic leadership for the establishment of a robust data integrity program based on risk analysis. In addition to identifying opportunities and implementing medium to long term strategies to mitigate data integrity risks based on trends and new developments in the data integrity industry.
- Lead the escalation of all data integrity related issues to site management levels as needed.
- Provide oversight for the governance, management and coordination of activities related to the Data Integrity Program, which includes, but is not limited to, leading, developing and maintaining data integrity compliance activities throughout the product lifecycle in alignment with regulations and GMP guidelines. Drive continuous / sustainable improvement in data integrity risk detection and mitigation through self-inspection program, continuous improvement program, Gemba walks, etc.
- Identify training needs, design, develop and deliver data integrity training on a regular frequency.
- Ensure compliance with all regulatory requirements related to data integrity, company policies and procedures, including security rules and regulations. Identify high-risk processes and data systems (through risk assessment, gap analysis, data mapping, etc.) and implement mitigation actions.
- Interact directly with FDA, other regulatory agencies and auditors on all issues related to data integrity. This includes supporting preparation for customer inspections, health authorities and/or responding to observations during audits.
**Qualifications and Experience**
- Bachelor’s Degree plus a 10 years experience in the pharmaceutical/biopharmaceutical industry supporting manufacturing and quality operations.
- Experience and in-depth knowledge of GxP computerized systems validation and 21 CFR Part 11, GAMP 5 and CSV requirements (including cloud systems, agile software development validation), methods validation and IT infrastructure qualification. Experience in US FDA, UK MHRA, PIC/s, EU, TGA, etc. data integrity guidelines.
- Experience in FDA regulated environment - US 21 CFR Part 210 & 211 Current Good Manufacturing Practice. Experience in dealing directly with FDA.
- Cross-functional experience in the pharmaceutical industry regulated by GxPs (i.e. manufacturing, engineering, quality assurance, quality control, etc.).
- Direct experience related to data integrity in the pharmaceutical/biopharmaceutical industry. Strong experience in data integrity program support, risk analysis, project and budget management.
- In-depth knowledge of data integrity requirements US FDA, UK MHRA, PIC/s, EU, TGA, etc.
- In-depth knowledge in validation of computerized GxP systems.
- In-depth knowledge in the requirements of 21 CFR Part 11, GAMP 5 and data integrity guidelines of USFDA, UK MHRA, PIC/s, EU, TGA, etc.
- Expert level knowledge and understanding of cGMP.
- Pharmatech Associates, Inc. provides _**_equal employment opportunity_**_ to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law._
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