Head of Quality Audit

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Description of the role:

We are looking for a highly skilled pharma-GMP auditor and risk management leader. This leader will have a significant amount of quality auditing experience across diverse technologies, working with systems-based audit approaches that cover all aspects of clinical, commercial and development pharma-GMP systems and biotechnology sectors. This leadership role will require strategic vision, strong analytical skills and a deep commitment to quality 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 integrity, depth, and accuracy in our approach, with a dedication to carrying out a premier audit program.

• Develop and implement a strategic audit plan, aligned with organizational goals and risk profiles and monitor compliance across all company organization.
• Lead, mentor and develop a high-performing quality audit team to support both internal and external audit processes
• Provide strategic direction on quality compliance initiatives, industry best practices, and continuous improvement
• Proven track record in influencing cross-functionally, balancing stakeholders, driving change management, and implementing a robust, effective, and strong quality audit framework.

How you will make an impact:

Becoming a key player in the mission to holistically assess the state of quality and regulatory compliance across PSG global manufacturing/testing sites via fully independent audit program. Helping to minimize risk across the sites and achieve successful regulatory inspections. Contributing towards the success of PSG and the services/products provided to clients and patients.

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 develop and maintain a PSG Corp Audit Plan in alignment with Audit Senior Leadership Team (SLT) to ensure audits are completed in accordance with PSG Quality Audit Policy.

We move strategy to action 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 within Thermo Fisher PSG's internal manufacturing network.

We promote positive Quality and leadership values such as: Creating environments for learning, harnessing lessons learned to drive continuous improvement, sharing standard methodologies, better practices, effective and open communication; and encouraging cross-functional partnerships.

We partner with business line leaders and Division Quality leaders to drive continuous improvement across the company, playing a critical role in maintaining Thermo Fisher’s commitment to Quality.

We participate in quality compliance projects related to auditing (e.g. detailed trend reports, data analysis, reviewing global PSG policies, and developing auditor training materials for quality auditors in the PSG network, etc.).

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.

How will you get here?

Minimum of 20 years professional working experience in Pharmaceutical Industry, including Manufacturing, Quality Control, Quality Assurance, CMC, Regulatory or related 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 develop talent. Proven track record in designing, building and implementing a robust pharma focused audit program.

Career path:

Opportunity for a leadership role with influence at the group level

Leadership role in partnership with the Quality function across the full Thermo Fisher enterprise

Knowledge, Skills, Abilities:

Must be an expert Quality compliance auditor. Proven track record in designing, building and implementing a pharma audit program. 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 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 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. Broad working knowledge of global pharmaceutical regulations and industry standards: EU GMP, US GMP, PIC/s GMP, MHLW GMP, WHO GMP, ISO 19011 (auditing quality management systems), ISO 15378 (primary packaging materials).

Education

Bachelor’s degree in pharmacy, Science or Engineering. Advanced degree in related field preferred.

Location: Remote; 50-70% Travel based on business needs

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!