Manager – Clinical Quality Assurance

Description

Summary

This position supports the Arcus Clinical Quality Assurance (CQA) team in support of CQA annual objectives in provision of support to Arcus Clinical Development therapeutic areas and clinical study teams. The key activity of the role is to provide active support for the management of clinical trial quality assurance activities.

The Manager, Clinical Quality Assurance will support clinical quality objectives and related activities outlined in the overall annual quality plan, using the quality plan, quality management system, quality tools, and relevant leadership guidance. Activities may include clinical trial team meeting attendance, study related quality activities, development of the study quality plan, oversight of clinical trial activities including vendors and sub-vendors, investigational medicinal product supply quality assurance activities, clinical trial quality activity monitoring, conducting effectiveness checks, report development, and tracking compliance with ICH-GCP and Arcus Standard Operating Procedures (SOPs) for the conduct of clinical studies.

In addition, the Manager, CQA, may partner with other key clinical functions, as assigned, to enable transparency and support addressing quality and compliance matters, as assigned. The Manager, CQA, will utilize regulations, guidances, policies, procedures, systems, trackers, tools, and templates, routinely, in supporting clinical quality assurance activities. 

Responsibilities

• Collaborate with stakeholders, as needed, to gain up to date information for tracking key clinical QA activities (i.e., database reports, form completion, critical form review, inspection readiness).

• Manages and maintains electronic quality management systems in support of on-going clinical quality activities.

• Supports the conduct of external GCP audits of clinical service providers, CROs, and suppliers.

• Supports the conduct of Investigator site audits for applicable clinical trials.

• Supports the conduct of internal process audits for clinical and pharmacovigilance functions.

• Identifies and escalates significant compliance issues to clinical QA and relevant leadership, including the assessment of serious breaches. Supports investigations related to identified issues.

• Participates as member of clinical study teams for assigned Therapeutic Areas/Studies, in ensuring compliance with ICH-GCP and applicable policies and procedures.

• Establishes relationship with CRO Quality Team members (as applicable) for the ongoing review of quality and compliance issues.

• Supports presentation development for GCP training to Clinical functions based on identified needs.

• Contributes to data collection of audit and inspection trends and metrics for CQA monitoring, audits, investigations, updates and presentations.

• Timely completion of tasks and follows-up with status updates on open action items.

• Maintains and further develops expertise in international GCP regulations and internal policies and procedures (using reference material) that may impact drug development. Asks questions, ask for help or clarification, and guidance, asneeded.

• Liaise with respective training functions to assess job role training requirements and participate in the development and execution of GCP, SOP or policy-related training (as required)

• Provide support and guidance during and following internal audits and external regulatory inspections (as required)

• Support Inspection Readiness program and make recommendations for its continuous improvement

• Participate on quality and compliance initiatives, as assigned

Qualifications

• Bachelor’s degree in scientific, health sciences or quality-related field.

• 3+ years in a pharmaceutical drug development GCP and /or Clinical QA related discipline.

• Trained and knowledgeable in international GCP drug development regulations, including USA (FDA), EU (EMA, MHRA) and ICH- GCP Guidelines.

• Previous experience managing quality and GCP compliance issues.

• Quality Certification and Clinical Supply QA Management experience is highly desirable

• Experience with cross-functional stakeholder management.

• Strong knowledge of the drug development processes (Ph I – IV)

• Must be flexible and comfortable with a risk-based approach to quality and ownership of quality across functional lines.

• Ability to influence people and affect change

• Ability to navigate and negotiate cross-functionally, in a matrix organization, to resolve conflicts.

• Ability to build and sustain meaningful relationships with business stakeholders and partners.

• Pro-active, solution-oriented mindset and sound judgment for evaluation of risks, guidance, and escalations

• Strong project management skills including team leadership, consultative facilitation, risk analysis, follow-through, and project planning.

• Strong interpersonal and organizational skills; Highly self-motivated, strong team-player, well-organized, confident, possesses a solution-oriented mindset and able to develop innovative solutions to issues.

• Strong verbal and written communication skills; detail oriented, uses discretion and critical thinking skills

• Strong computer literacy in MS Word, Excel, Project, Visio, PowerPoint., Clinical and Quality databases.

Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person, before groups, and over the telephone. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment. Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds.