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RCM Technologies Director/Sr. Director, CQA, GCP Inspections Management in Gaithersburg, Maryland

Reference # :20-00967Title :Director/Sr. Director, CQA, GCP Inspections ManagementLocation :Gaithersburg, MDPosition Type :Direct PlacementExperience Level :Start Date :11/23/2020 Description

We are seeking a Quality Assurance Director/Sr Director to join our Quality Assurance department. The Director/Sr Director will be primarily responsible for overseeing the coordination with Clinical Immunology and Clinical Operations for Clinical Quality Assurance (CQA) review and approval of GLP/GCLP data and associated documentation, including Deviations and CAPA. The candidate will support revisions to the quality management system procedures and electronic solution. Additionally, the Director/Sr Director will work with Quality Assurance and partner groups in support of compliance issues and contract testing, clinical, and auditing organizations.

This position reports directly to the Senior Vice President, Quality Assurance.

Responsibilities include but are not limited to:

  • Serves as a technical resource or subject matter expert on methods and techniques within Quality Assurance

  • Manages day to day tasks for junior employees and supervisors

  • Performs lead role on complex issues with minimal input from senior staff

  • Conducts final review and approval of GLP/GCLP data and associated documentation

  • Approves Deviations, CAPA and Change Controls

  • Manages the execution, review, and approval of qualification, validation and tech transfer activities

  • Delivers training for individual/small group/large group training

  • Generates, reviews and approves controlled documents (i.e., SOPs, Specifications, Methods, Protocols, Reports, etc.)

  • Manages projects and delivers outcomes within desired timeline

  • Identifies and coordinates resources and effectively communicates process, outcomes and timelines

  • Supports local and global Quality Assurance functions

  • Serves as technical resource or subject matter expert for the acquisition and use of GxP-related technology

  • Manages and leads teams on complex GxP compliance events

Minimum Requirements:

  • BS with 12+ years experience in the Pharmaceutical/Biotech industry with 3+ years supervisory experience

  • Excellent communication and organizational skills

  • Excellent understanding of GMP, GLP, GCP and GCLP expectations

  • Knowledge of global regulatory expectations (including FDA and EMA)

Preferred Requirements:

  • Established recognition as a technical expert

  • Demonstrated success leading multiple teams

  • Demonstrated success in developing junior staff and supervisors

  • Demonstrated complex problem resolution through assignment of work to staff

  • Demonstrated ability and willingness to perform tasks with increasing independence and complexity

  • The ability to represent QA cross-functionally and globally; to apply understanding of the team's place in the larger organization, and discuss changes, progress, and issues as they relate to other areas

  • The flexibility to influence a prompt and constructive response of the team when change is encountered or necessary; to apply perspective to lead more junior teammates and cross-functional partners through change

  • The accountability to attain confidence in achieving complex deliverables requiring cross-functional and, at times, global involvement

  • The ability to produce high-quality work on complex problems with cross-functional and global impact; to take ownership of quality considerations and standards across the team's work product

  • The capability to mentor junior team members (including supervisors); to work cross-functionally as the representative for their area and lead cross-functional work; to contribute to work outside their own area of expertise; to network with key contacts outside own area of expertise; and mentor peers and senior team members within the team

  • The capability to model, lead, train and motivate multiple levels of employee to be exceptional collaborators

This position may require periodic weekend/evening work.

RCM Technologies is a leading provider of IT Business Solutions and Engineering Services to over 1,000 clients in the commercial and government sectors. RCM partners with clients to define implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.RCMTechnologies, (USA) Inc. is an Equal Opportunity Employer M/F/D/V. RCMT encourages applicants of all ages.

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