Senior Manager Quality GCP 8/23/2016

Robsco Search Ardsley, NY

Company
Robsco Search
Job Classification
Full Time
Company Ref #
28924695
AJE Ref #
575962792
Location
Ardsley, NY
Job Type
Regular

JOB DESCRIPTION

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Senior Manager - Quality GCP

The Senior Manager - Quality GCP is responsible for performing domestic and international audits/inspections that ensure compliance with the FDA and other worldwide health authority GCP regulations and guidelines, site SOPs, protocols, and industry standards, as applicable. This individual provides recommendations for corrective and preventative action to the Quality Senior Management team and tracks commitments until closure.

Summary:

The Senior Manager - Quality GCP is responsible for performing domestic and international audits/inspections that ensure compliance with the FDA and other worldwide health authority GCP regulations and guidelines, site SOPs, protocols, and industry standards, as applicable. This individual provides recommendations for corrective and preventative action to the Quality Senior Management team and tracks commitments until closure.

*Essential Duties and Responsibilities include the following. Other duties may be assigned.

Plans and conducts document, internal and external GCP audits of clinical research activities to assess compliance with FDA, ICH GCP, and local regulations, as well as with protocol and company SOPs. Routine reviews of documentation include, but are not limited to protocols, case report forms, tables and listings, investigator brochures, informed consent forms and clinical trial reports.
Audits and evaluates service providers (e.g. clinical investigational sites, CROs, vendors), as appropriate, to assess capabilities and compliance with applicable regulations as well as with company policies and procedures.
Prepares clear and concise written reports of audit observations, including an assessment of compliance. Presents QA findings to in-house client staff and, if appropriate, to the responsible individuals at service providers. Works closely with departmental staff and Service Providers to identify, evaluate, and recommend solutions to issues identified in the performance of GCP audits.
Evaluates corrective and preventative action responses to audit findings for adequacy and timeliness and manages the closeout of all corrective and preventative actions.
Develops audit plans for clinical studies.
Plans and conducts domestic and international inspections.
Applies departmental SOPs and participates in the development of departmental SOPs, as appropriate.
Reviews internal SOPs and external SOPs.
Maintains Quality documentation files, databases and logs. Tracks metrics and trends as well as compliance issues and their resolution on a periodic basis. Provides audit related metrics to Senior Management.
Participates on Process Improvement teams.
Assists with GCP internal training internally and where required external of investigators and service providers.
Acts as a key point of contact for staff, providing information and expert guidance on regulations and procedures related to GxP and Quality to associates.
Ensures project deadlines and performance standards are met.
Ensures compliance with all of policies and procedures including safety rules and regulations.
Works with the Head of Quality to assure alignment and compliance with Quality Management System, supports assessment of compliance and defines metrics to determine performance objectives.
Provides support during compliance inspections conducted by external sources (i.e. health authorities), as applicable.

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 seven years progressive experience in the regulatory compliance environment.
Minimum of five years Quality auditing experience in the Biotechnology or Pharmaceutical industries required.
Prior supervisory experience preferred.

Qualifications:

Strong knowledge of GCPs, FDA regulations and ICH guidelines required. Knowledge of EMA 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 electronic data capture systems 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 multi-task and adjust priorities, as necessary.
Ability to effectively present information to management.
Ability to participate on interdepartmental teams
Ability to interact effectively with all levels of associates both internally and externally, including investigators and study site personnel.

Physical Demands:

This position requires travel; average travel for this position is 25% 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.