GCP/GLP Quality Audit Report Processor-Contract

Company Description

Sia Partners is a next-generation consulting firm focused on delivering superior value and tangible results to its clients as they navigate the digital revolution. Our global footprint and expertise in more than 40 sectors and services allow us to enhance our clients’ businesses worldwide. We guide their projects and initiatives in strategy, business transformation, IT & digital strategy, and Data Science.

Job Description

Latham BioPharm Group, a part of Sia Partners, provides the insight, knowledge, and network to unite teams and technologies in the Life Sciences. We provide the depth of expertise necessary to advance programs, by providing a range of life science services including business development, program management, CMC, non-clinical, quality, regulatory, and strategic consulting with proven experience in biodefense/pandemic response and strategic product development.

Project Length: 9 Months

Location: Remote, Boston, MA preferred

Responsibilities:

• Supporting the execution of the QA Master Audit plan ensuring the conduct of GCP, GCLP, GLP related audits.  These audits could include investigator site audits, service provider audits, computer system validation audits, document audits and internal system/process audits.  The oversight will span from scheduling of audits through closure of audits. 
• Schedule Audits
• Determine Auditor
• Contact Auditee
• Compare and Review dates
• Introduce Auditor to Auditee
• Kick-Off Meeting scheduled with individuals identified by auditor and audit lead
• Create new Audit in Veeva Vault
• Schedules Audit Debrief meeting scheduled individuals identified by auditor and audit lead
• Tracks audit report due dates
• Tracks audit report response due dates
• Provides high level review of CAPA responses – sends to audit lead for approval
• Tracks audit closure – after auditee responses completed and acceptable.

Qualifications

• 5+ years of relevant experience in clinical operations research, auditing of clinical investigator, and service providers a plus
• Minimum of Bachelor’s Degree required
• Experience in pharmaceutical development with a good understanding of the drug development process. 
• Ability to manage review of audit response corrective and/or preventative actions from the audit observations using root cause analysis and risk-based approach.
• Attention to detail and accuracy in work
• Knowledge in the US and EU ICH/GCP regulations and guidelines.
• Knowledge of EMA GCLP Guidance and GLP Regulations
• Excellent verbal and written communication skills.
• Critical thinker with ability to synthesize information from multiple sources and apply problem solving
• Trustworthy with highest integrity, committed to ethics and scientific standards
• Team-oriented, collaborate style with the ability to build consensus amongst internal and external constituents.
• Energetic, positive, and flexible attitude
• Hands on experience using Veeva Vault for documentation purposes a plus
• Flexibility and ability to deal with ambiguity, and sense of personal ownership of deliverables and results.
• Ability to work well within a team or independently.

Additional Information

Our Commitment to Diversity

Diversity, equity, inclusion, and belonging (DEIB) are part of Sia Partners’ DNA. Thanks to our expertise in several sectors and our international growth, our teams include a variety of experiences and cultures. We’re confident that promoting DEIB creates an environment in which everyone can reach their full potential.

Our global network, DEIB@Sia Partners, brings together our people worldwide to facilitate local and global progress, focused on the following areas:

• Gender equality (global Gender Equality Index score of 91/100 for FY19-20)
• LGBTQ+
• Race & Ethnicity
• Working Parents
• Disabilities

Sia Partners is an equal opportunity employer. All aspects of employment, including hiring, promotion, remuneration, or discipline, are based solely on performance, competence, conduct, or business needs.

To learn more about our mission, values, and business sectors, please visit our website.

Sia Partners is an equal opportunity employer. All aspects of employment, including hiring, promotion, remuneration, or discipline, are based solely on performance, competence, conduct, or business needs.