Biologics and Pharmaceutical Industry Leader seeks Senior Director of Global Quality Auditing to oversee North and Latin American teams that manage agency inspections globally and across all different product markets:
Initial Top Challenges:
1) Direct audit leadership teams in:
a. Ensuring sites are prepared for Regulatory Agency Inspections. Special focus will be on FDA Pre-Approval Inspections readiness through FDA “Mock” inspections, audit and support activities and training
b. Defining, implementing and maintaining of Quality Systems & Quality Product Standards
c. Management of interfaces with Regulators & Health Authorities, Clients and Suppliers
2) Lead planning and group discussion of changes to corporate documents and policies as a result of you analysis of inspection findings and identified deficiencies
3) Maintain strong relationships and continual dialogues with the FDA to make sure your global sites and product markets understand inspection findings, issues ands evolving regulations
4) Identification and communication of emerging GMP, Regulatory and Industry trends identifying, promoting and communication of “best practices”.
5) Oversee compliance readiness within region and worldwide in pharmaceutical technology for all product forms and with a particular emphasis on biological products, vaccines, zoning concepts, environmental monitoring, utilities and quality systems.
Longer Term Challenges:
6) Development of comprehensive quality, auditing, audit certifications and inspection readiness training programs
7) Further develop the depth and skill of a "pool" of auditors throughout the global organization
8) Lead site assessments and provide input into business cases for sites needing to go through remediation or facility upgrades. As part of this, participate in the planning, review and approval of GMP related issues of new or remodeled facility layouts, including IQ/OQ/PQ validation activities.
Salary: Base will be DOE. Bonus and relocation eligible too
Location: New Jersey
Travel: 30%-40% and primarily in the US and Europe
Contact : Apply below and/or at www.fpccareers.com and/or contact Ira Mann at email@example.com
1) B.S. degree (or advanced degree) in a scientific field.
2) 15+ years combined experience in Pharmaceutical Quality, Auditing and FDA GMP inspections
3) Management experience (multi national preferred)
4) Extensive experience and expertise in global and regulatory laws, requirements and expectations, including, but not limited to, FDA CFR, EU and WHO requirements.
5) Strong knowledge of Biologics, Vaccines and/or other CBER regulated products
6) In-depth knowledge of zoning concepts, environmental monitoring, utilities, quality systems, etc.
7) Knowledge of Latin American regulatory requirements and cultures.
8) Ability to influence and negotiate areas of GMP regulatory requirements and expectations
9) Ability to present audit findings in a clear, concise and diplomatic way to the site and all levels of Management
1) Experience as a FDA GMP inspector (strongly preferred)
2) Proficiency in Spanish or French
3) Broad experience across dosage forms and in pharmaceuticals, generics and biologics
4) Full product lifecycle experience
5) Knowledge of the structure and decision making processes of regulatory bodies
Key Words: FDA, auditing, mock audit, PAI, zoning concepts, environmental monitoring 3PI, quality systems, GMP, biologics, vaccine, CBER, training