Deerfield Management Companies

Associate Director Clinical Quality

Job Locations US-MD-Gaithersburg
Job Post Information* : Posted Date 3 weeks ago(6/7/2022 12:57 PM)
ID
2022-1783
# of Openings
1
Category
Research & Development

Overview

Adaptive Phage Therapeutics (APT) is a clinical-stage biotech advancing therapies to treat multi-drug resistant infections. We are on a mission to address today’s — and tomorrow’s — toughest infections. We are looking for intelligent and motivated people to help us reach those goals.

 

We are seeking an Associate Director, Clinical QA to join our team. The candidate should have experience with GCP/GCLP/GLP/PV regulations, guidance documents, and industry best practices within a GxP environment. Additionally, solid experience building Quality systems and working with outsourced clinical activity (e.g., trials, testing, CROs) is desired.

The Associate Director, Clinical QA will manage the day-to-day responsibilities and accountabilities of Clinical QA. The Associate Director, Clinical QA will work collaboratively across internal functions including Clinical, Clinical Operations, Clinical Testing Laboratory, Quality Assurance, Regulatory Affairs, and Supply Chain to ensure CQA deliverables are met. Lead the design of phase appropriate CQA systems including implementation and continuous improvement to ensure patient safety, regulatory compliance, and data integrity. Provides leadership, direction, and mentorship across all levels of the organization to assure CQA strategies are known and implemented. Acts as primary SME on CQA matters, internally and externally.

Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

  • Responsible for day-to-day operations and accountabilities of CQA.
  • Works as CQA POC to provide technical and compliance expertise, direction, and decision, where needed.
  •  Leads the development, implementation, and maintenance of CQA systems. Ensures consistency (where applicable) to GMP Quality systems and practices.
  • Writes, reviews, and/or approves technical documents such as audit plans/reports, protocols, deviations, change controls, investigations, and SOPs.
  • Leads CQA oversight duties (investigator sites, clinical vendor sites/CROs, internal, and/or partner).
  • Participates in regulatory inspections, which may include preparing content for inspection readiness programs, planning and leading mock inspections, and leading (if needed) risk mitigation and/or remediation centric discussions.  
  • Resolves compliance issues at clinical sites, clinical vendors, and laboratories; and provides impact assessments, where needed.
  • Reviews, tracks and/or trends routine quality data and metrics. Reports adverse trends to senior management, including suggested risk mitigation and/or remediation actions.
  • Stays current with changes to current regulatory compliance landscape, including FDA, EU, and other regulatory bodies relevant to APT activities.
  • Other duties as needed. 

Full COVID-19 vaccination required; APT employees are required to be fully vaccinated against COVID-19 to work on the premises.

 

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required for this job. Duties, responsibilities, & activities may change at any time with or without notice.

Qualifications

  • Bachelor’s Degree in a medical related field or life sciences preferred
  •  7-10 plus years of experience in clinical quality assurance role
  •  Previous experience providing direct day to day management and oversight of clinical quality assurance accountabilities and responsibilities
  • Skilled in development and implementation of phase-appropriate quality systems
  • Solid understanding of FDA and other regulatory requirements that impact clinical studies and testing
  • Thorough knowledge of ICH GCP guidelines
  • Advanced competence in collaboration, teamwork & communication
  • Strong organizational skills with demonstrated success required
  • Ability to influence and solve complex technical and compliance issues

 

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job and will be available to the candidate upon request.

 

APT is an Equal Opportunity/Affirmative Action employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. APT seeks to diversify its work force and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

 

Notice to Third-Party Recruiters/Staffing Agencies: Recruitment is managed through the Adaptive Phage Therapeutics Human Resources department. Resumes will only be accepted from staffing agency/recruiters if there is a signed contract in place. Recruiters are requested to not contact our hiring managers or employees directly to inquire about open positions or to present candidates. In the event a staffing agency/third-party recruiter submits a resume without a contract in place, the candidate submitted will be considered unsolicited and treated as if the candidate submitted their resume directly to Adaptive Phage Therapeutics, and no fee/payment will be paid. Recruiters interested in working with Adaptive Phage Therapeutics can submit their information to hr@aphage.com and we will contact you if needed.

 

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