Associate Director, GCP QA & Compliance (remote-based)

Hobson Prior are currently seeking for an Associate Director, GCP Quality Assurance & Compliance to join a brilliant biotech organisation on a permanent basis with the ability to work remotely from anywhere within the US. Our client is focused on supplying life-changing innovations for people.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this position, you will guide/conduct for-cause audits or any other high-profile audits, projects, and/or special investigations to review non-compliance, root cause recognition, and document outcomes and inform management.
• Organise the development, upkeep and distribution of GCP training programs.
• Serve as the QA main point of contact for supplier QA-QA relations when required.
• Monitor/perform/organise training for outlined SMEs and guarantee setup of pre-inspection meetings for line unit heads and suitable personnel.
• You will train, assist, and/or handle the actions of QA/C staff both internally and externally.
• When allocated, you will outline, execute, and/or guide GCP QA and/or business/cross functional annual objectives and initiative.
• Support management in planning for regulatory agency inspections and in the ratification of an 'inspection promptness' program for the company.
• Guarantee production/upkeep of papers for pre-inspection planning.
• The ideal candidate will conduct QA risk examinations and assist or handle the GCP/GLP/GPV risk-based audit program annually.
• Any other assigned duties.

Key Skills:

• Social and communication skills both verbally and in writing.
• Works well in a team environment and is adaptable without compromising quality of work.
• An organised individual who manages their time efficiently.
• Capable of meeting deadlines and commitments with a high attention to detail to provide high quality work.
• Ability to cooperate cross functionally and across geographies to complete tasks while motivating others.
• Able to handle various tasks simultaneously within an energetic setting.

Requirements:

• Educated to a degree level in a healthcare and/or scientific field.
• At least 6-10 years of experience with GCP quality assurance within a pharmaceuticals or biotechnology organisation.
• Familiarity with GLP and/or PV auditing would be advantageous.
• Comprehension of clinical development processes, FDA GLP, GCP and ICH regulatory needs and execution.
• Know-how of computer system validation affiliated with GLP/GCP.
• Prior involvement with hosting or contributing to regulatory inspections such as FDA, EMA, MHRA, etc.
• Acquaintance with risk management or risk-based approach to auditing and monitoring would be beneficial.
• Familiarity with authoring and evaluating SOPS which assist clinical trials.
• Willing to travel for business needs up to 40% - 50% of the time both locally and globally.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.