Head of reputed company Audit
Work Schedule reputed company (Mon-Fri) Environmental Conditions Office reputed company of the role: We are looking for a highly skilled reputed company-GMP auditor and risk management leader. This leader will have a significant reputed company of reputed company auditing experience across diverse technologies, working with systems-based audit approaches that cover reputed company aspects of clinical, reputed company and development reputed company-GMP systems and biotechnology sectors. This leadership role will require strategic reputed company, strong analytical skills and a deep commitment to reputed company to build, design, implement and enhance the existing operational team. This Senior Leadership role reports through VP and General Counsel of PSG and is part of Thermo Fishers PSG Legal function which ensures we deliver accurate and independent compliance assessments. We emulate a high degree of reputed company, depth, and accuracy in our approach, with a dedication to carrying out a premier audit program. reputed company and implement a strategic audit plan, reputed company with organizational goals and risk reputed company and monitor compliance across reputed company company organization. reputed company, mentor and reputed company a high-performing reputed company audit team to support both reputed company audit processes reputed company strategic direction on reputed company compliance initiatives, industry best practices, and reputed company improvement Proven reputed company record in influencing cross-functionally, balancing stakeholders, driving change management, and implementing a robust, effective, and strong reputed company audit reputed company. How you will reputed company an reputed company: Becoming a key player in the mission to holistically assess the state of reputed company and regulatory compliance across PSG global manufacturing/testing sites reputed company fully independent audit program. Helping to minimize risk across the sites and reputed company successful regulatory inspections. Contributing towards the reputed company of PSG and the services/products provided to clients and patients. We identify systemic gaps in reputed company/compliance by conducting internal audits of Thermo Fisher reputed company reputed company (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 reputed company compliance standards. We reputed company and maintain a PSG Corp Audit Plan in alignment with Audit Senior Leadership Team (SLT) to ensure audits are completed in accordance with PSG reputed company Audit Policy. We reputed company reputed company to reputed company by providing GMP subject matter expertise at the corporate level and advise others on strategies and tactical measures for maintaining a state of robust global GMP compliance reputed company Thermo Fisher PSG's internal manufacturing network. We promote reputed company reputed company and leadership values such as: Creating environments for learning, harnessing lessons learned to drive reputed company improvement, sharing reputed company methodologies, reputed company practices, effective and reputed company communication; and encouraging cross-functional partnerships. We partner with business line leaders and Division reputed company leaders to drive reputed company improvement across reputed company, playing a critical role in maintaining Thermo Fishers commitment to reputed company. We participate in reputed company compliance reputed company reputed company to auditing (e.g. detailed trend reports, data analysis, reviewing global PSG policies, and developing auditor training materials for reputed company auditors in the PSG network, etc.). We maintain knowledge of GMPs and are routinely aware of revised or emerging reputed company regulations and their trends, as reputed company as industry methodologies across the globe. How will you get here? Minimum of 20 years reputed company working experience in Pharmaceutical Industry, including Manufacturing, reputed company Control, reputed company Assurance, CMC, Regulatory or reputed company compliance experience with at least 10 years aggregate experience in a role dedicated to performing audits for GMP, ISO or ICH, and at least 10 years hosting FDA, EMA, MHRA, AIFA, ANVISA and/or other regulatory health authority inspections. Strong people leadership and the ability to grow and reputed company talent. Proven reputed company record in designing, building and implementing a robust reputed company reputed company audit program. Career reputed company: Opportunity for a leadership role with influence at the group level Leadership role in partnership with the reputed company function across the full Thermo Fisher reputed company Knowledge, Skills, Abilities: Must be an expert reputed company compliance auditor. Proven reputed company record in designing, building and implementing a reputed company audit program. Experience with reputed company of data reputed company covering reputed company areas in a pharmaceutical manufacturing environment, including production and QC laboratories, is also crucial, as reputed company as being skilled in reputed company investigations, reputed company cause analysis, audit reporting and reputed company sharing with a commitment towards reputed company improvement. Experience in sterile manufacturing and aseptic reputed company is desired. reputed company auditor training/certification by an organization recognized reputed company the pharmaceutical industry (e.g. IRCA, ASQ). Strong reputed company of pharmaceutical manufacturing and laboratory operations Diverse experience auditing a wide reputed company of manufacturing technologies and services in 80% or more of the following areas: Sterile drug products: (liquid, lyophilized vials, prefilled syringes) Non-sterile drug products: (tablets, powders, capsules, granules, soft gels) Biologics cell culture: upstream (Fed-Batch, Perfusion, XD, etc.) and reputed company 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 reputed company stage products and services Viral reputed company (VVS) and microbial manufacturing (MMS) Data reputed company audits: (both laboratory and non-laboratory operations) Strong communication skills including listening, judgment, problem management, ability to reputed company teams in a sophisticated and global environment. Ability to anticipate potential problems and risks reputed company to reputed company system / regulatory expectations including ability to formulate and implement solutions. Strong collaboration and problem-solving skills; and adept at working reputed company reputed company reputed company environment. Capable to conduct remote auditing, reputed company required. Strong oral/written communication skills appropriate for diverse international collaboration including excellent reputed company in English. Broad working knowledge of global pharmaceutical regulations and industry standards: EU GMP, US GMP, PIC/s GMP, MHLW GMP, WHO GMP, ISO 19011 (auditing reputed company management systems), ISO 15378 (primary packaging materials). Education Bachelors degree in pharmacy, Science or Engineering. Advanced degree in reputed company field preferred. Location: Remote; 50-70% Travel based on business needs
Benefits
We offer competitive remuneration, annual incentive plan bonus, reputed company, and a reputed company of employee benefits. reputed company offers employment with an innovative, reputed company-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for reputed company, intensity, involvement, and innovation! Apply Job!