CAREER PORTAL

Sr. Manager, R&D Quality Assurance

Sr. Manager, R&D Quality Assurance
Cambridge, MA (Hybrid, 2 days onsite)
Contract, 6 months +
Pay Rate:  $95 - $100 per hour (depending on experience)

***CDA will be required for an interview

Minimum of 5 years’ experience with:

• Strong GCP experience with clinical operations oversight.
• Experience with quality events, outsourced audits
• Support for study teams across phases 1,2, and 3

Other Qualifications: Educated to bachelor’s degree level, preferably life science (technology, biological science, pharmacy, or other health related discipline preferred) or equivalent qualification or clinical research experience. Master’s degree in a science, technology, or industry related discipline, preferred.

• Seven years’ experience in GCP Quality Assurance, or similar experience working in GCP and clinical trial that support pharmaceutical development.
• Experience in Overseeing late phase clinical trials.
• Experience in leading audits.
• Experience supporting and leading inspections readiness efforts and direct inspection experience.
• Extensive experience working with different Quality Assurance functions, knowledge of Auditing, Clinical Supply Chain, Clinical Operations, Monitoring, Regulatory Affairs, Clinical Research, Drug Safety and Data Management and Statistics
• Strong working knowledge & knowledge of how to interpret GCP regulations as well as industry guidance (e.g., FDA, EMA, and other national agencies).

Responsibilities:

• Independently perform the duties of the QA Program Lead (PL) role, providing Clinical Quality Assurance oversight of assigned clinical studies, ensuring the conduct and compliance of clinical trials in alignment with the Protocol, International and Local Regulations.
• Lead inspection readiness for assigned studies and lead/support audit activities as required.
• Independently execute the R&D Program Lead (PL) role, with escalation support from the GCP QA director, as guided by Program Lead Plan.

The PL role will be working with Expertise Areas to oversee key areas of compliance with the protocol, company SOPs (Standard Operating Procedures), Good Clinical Practice (GCP), and Regulatory Guidance, including:

• As directed by the PL Plan and with consideration to the risk and complexity of the clinical trial
• Lead the development and execution of study audit plans, support Investigator Sita Audit (ISA) selection, develop audit agendas, audit reports, and CAPAs (Corrective Action and Preventive Action) for managed audits or oversee CRO managed ISA activities. Co-audit/lead ISAs, as required.
• For Phase 2 & 3 trials, lead the development and execution of quality activities through endpoint de-risking to identify, manage, and report key study risks.
• Develop and execute PL Oversight of assigned clinical studies as guided by the PL Plan, this includes, but is not limited, to risk-based reviews of key study documents against the PL Plan, and assessment of EA clinical trial activity and outputs in compliance Protocol, ICH-GCP, Health Authority guidance and regulations, procedural documents and best practices.
• Execute the Quality Event QA roles for study specific compliance issues, including sponsor non-compliance, clinical site non-compliance, and vendor non-compliance through guidance on appropriate investigations, root cause analyses, impact assessments, and corrective and preventive action plans.
• Provide guidance to other Program Leads and oversee assigned other R&D QA junior staff assigned to the study where the PL executes the PL role.
• Establish and maintain good working relationships with internal Expertise Area (EA) Leads and external partners.
• Provide ad-hoc GCP quality guidance to groups within the organization.
• Own and drive inspection readiness efforts for assigned clinical studies, with oversight from the Director, GCP QA (or designee);
• Oversee the completion of the IR workstream completion for all workstreams, including workstreams owned by EAs.
• Create workstreams for all Inspection Readiness topic areas, create inspection readiness workstreams with details for EAs on how to execute the workstreams, as required to be inspection ready for EMA (CHMP), FDA (BIMO), PMDA and other Health Authority inspections.
• Participate in preparation for regulatory inspections, overseeing assignment of all IR workstreams and owning assigned IR workstreams, providing guidance to EAs and other QA team members to deliver IR activities, core presentations and back-up presentations.
• Execute assigned roles in the front room and backroom and provide insight to the Process Quality Excellence team on who is best able to execute other front-room and back-room roles.
• Identify sites of interest and lead Site Inspection Readiness Training visits
• Management of inspection related CAPAs & Quality Events.
• Manage site level inspections, with support from the Director, GCP QA (or designee)

As directed by the GCP QA Director, support QA Vendor Quality Oversight (VQO) audit team:

• Provide input towards Vendor Audit scope for vendors that support assigned Clinical Trials
• Support the review of vendor audit and CAPA responses.
• Co-audit vendor audits as required.

As directed by the GCP QA Director, support QA Process Quality Excellence (PQE team):

• Support multi-study/process related QEs, as required.
• Lead and Co-Audit assigned Process Audits
• Participate in assigned Process Improvement initiatives, providing SME input.
• Participate in Program Lead Plan updates, PL tools, and QA SOP/WI updates.
• Support assigned Regulatory Intelligence reviews.

Travel on assignment, average of 10-25%.

Other assignments as directed by the Quality Assurance management team.


 

Estimated Min Rate: $95.00
Estimated Max Rate: $100.00


What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.