Ergomed plc provides specialist services to the pharmaceutical industry spanning all phases of clinical development, post-approval pharmacovigilance and medical information.

Ergomed’s fast-growing, profitable services business includes an industry leading suite of specialist pharmacovigilance (PV) solutions, integrated under the PrimeVigilance brand, a full range of high-quality clinical research and trial management services under the Ergomed brand (CRO), and an internationally recognised specialist expertise in orphan drug development, under PSR.

For further information, visit: https://ergomedplc.com.

Summary of Responsibilities:

The Senior Manager, Quality Assurance 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. 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 (e.g. phase I units, CROs, central drug depot, central laboratory).

- 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 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.

- Participates in system validation as business QA, e.g. review of the validation plan, validation report, risk assessment, GxP and ERES assessment

- Assists with GCP internal training internally and where required external of investigators and service providers.

- 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.

Extensive progressive experience in the regulatory compliance environment.

Extensive Quality auditing experience in the Pharmaceutical or CRO industries required.

Qualifications:

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 requirements.

Maintains professional expertise and knowledge of local and international regulations related to Quality and GCP.

Computer Skills:

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.

 Position Demands:

In regular times, this position requires travel; average travel for this position is 30% 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.