Job Title – Manager, Quality Assurance
Summary of Responsibilities: As QA Manager will be responsible for performing domestic and
international audits that ensure compliance with the EMA and other worldwide health authority GCP
regulations and guidelines, company SOPs, protocols, and industry standards, as applicable. This
individual provides recommendations for corrective and preventative action to the Quality /
Company Management team and tracks commitments until closure.
*Essential Duties and Responsibilities include the following:
– Plans and conducts document, internal and external GCP audits of clinical research activities to
assess compliance with EMA, ICH GCP, and local regulations, as well as with protocol and company
SOPs. Depending on auditor’s expertize, routine reviews may include, but are not limited to TMF
audits, investigational site audits, company systems audits (project management / monitoring,
regulatory affairs, medical writing, clinical safety, data management and biostatistics), and vendor
assessment audits (local CROs, wholesalers, archiving company, central laboratory, phase I units).
– Prepares clear and concise written reports of audit observations, including an assessment of
compliance. Provides audit related metrics to Senior Management. Evaluates corrective and
preventative action responses to audit findings for adequacy and timeliness and manages the
closeout of all corrective and preventative actions.
– Provides support during preparations and hosting audits /inspections conducted by Sponsor
companies / health authorities, as applicable.
– Assists with development of audit plans.
– Applies departmental SOPs and participates in the development of departmental SOPs.
– Assists with GCP internal training internally and where required external of investigators and
– Supporting Company staff by providing information and expert guidance on regulations and
procedures related to GxP and Quality.
– Ensures compliance with all of Company policies and applicable industry standards. Works with the
Head of Quality to assure alignment and compliance with Company’s Quality Management System,
supports assessment of compliance and defines metrics to determine performance objectives.
Education and/or Experience:
Bachelor’s degree in life sciences or related field required.
Master’s degree in life sciences or related field preferred.
Minimum of 3-5 years Quality auditing experience in the Pharmaceutical or CRO industries required.
Strong knowledge of GCPs, EMA regulations and ICH guidelines required. Knowledge of FDA and
other Health Authority requirements desired.
Must be able to interpret and apply GCP regulations and guidances, including 21CFR part 11
Maintains professional expertise and knowledge of local and international regulations related to
Quality and GCP.
Must be proficient in MS Office Suite.
Strong knowledge of and ability to navigate Health Authority Websites (e.g. FDA, EMA, ICH).
Prior hands-on experience with data management and validation process preferred.
Other Skills and Abilities:
Excellent written and oral communication and presentation skills.
Ability to prioritize and multi-task successfully in a fast paced environment.
Excellent organizational skills and attention to detail are essential
Ability to manage both day-to-day operations as well as project work.
Ability to work both independently and in a collaborative team setting.
Ability to effectively present information to management.
Ability to interact effectively with all levels of associates both internally and externally, including
investigators and study site personnel.
This position requires travel; average travel for this position is 40% with some variation based upon
the demands of the business imperatives. Travel is both domestic and international for the purpose
of auditing GCP related activities.