Sr Manager, ComplianceVerified as a real position

Who we’re looking for

• Minimum of 10 years professional working experience in Pharmaceutical Industry, including Manufacturing, Quality Control, Quality Assurance, CMC, Regulatory or related compliance experience with at least 5 years aggregate experience performing audits for GMP, ISO or ICH, and hosting/supporting FDA, EMA, MHRA, AIFA, ANVISA and/or other regulatory inspections.
• Must be an expert Quality compliance auditor.
• Experience with elements of data integrity covering all areas in a pharmaceutical manufacturing environment, including production and QC laboratories, is also crucial, as well as being skilled in quality investigations, root cause analysis, audit reporting and benchmark sharing with a commitment towards quality improvement.
• Experience in sterile manufacturing and aseptic practice is desired.
• Professional auditor training/certification by an organization recognized within the pharmaceutical industry (e.g. IRCA, ASQ).
• Strong foundation of pharmaceutical manufacturing and laboratory operations.
• Diverse experience auditing a wide range of manufacturing technologies and services in 30% or more of the following areas: Sterile drug products: (liquid, lyophilized vials, prefilled syringes) Non-sterile drug products: (tablets, powders, capsules, granules, softgels) Biologics cell culture: upstream (Fed-Batch, Perfusion, XD, etc.) and downstream purification processes (Chromatography, nano filtration, etc.) Chemicals, intermediates, API manufacturing: (synthesis, purification, drying, isolation, etc.) Packaging operations: (primary and secondary) QC laboratories (Analytical and Microbiological) IT / Computer systems validation Clinical and commercial stage products and services Viral vector (VVS) and microbial manufacturing (MMS) Data integrity audits: (both laboratory and non-laboratory operations)
• Strong communication skills including listening, judgment, problem management, ability to lead teams in a sophisticated and global environment.
• Ability to anticipate potential problems and risks related to quality system / regulatory expectations including ability to formulate and implement solutions.
• Strong collaboration and problem-solving skills; and adept at working well within a team environment.
• Capable to conduct remote auditing, when required.
• Strong oral/written communication skills appropriate for diverse international collaboration including excellent fluency in English.
• Bachelor’s Degree in Pharmacy, Science or Engineering. Advanced degree in related field preferred.

What you’ll do

• We identify systemic gaps in quality/compliance by conducting internal audits of Thermo Fisher Pharma Services Group (PSG) manufacturing and Clinical Trial Division (CTD) sites.
• We prepare detailed audit reports to communicate observations written in a meaningful and accurate way, so that readers can easily understand the conditions or gaps in compliance with regulations and quality compliance standards.
• We maintain knowledge of GMPs and are routinely aware of revised or emerging quality regulations and their trends, as well as industry methodologies across the globe.
• We promote positive Quality and leadership behaviors such as: creating environments for learning, harnessing lessons learned to drive continuous improvement; sharing standard methodologies; maintaining effective and open communication; and encouraging cross-functional partnerships.
• We also participate in ad-hoc quality compliance projects related to auditing (e.g. detailed trending reports, data analysis, reviewing global PSG policies, and preparing auditor training materials for internal/external quality auditors in the PSG network, etc.).

About the position

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Benefits

• We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
• As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers.
• We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
• Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.