Associate Director, Early Development reputed company reputed company, R&D QA

Associate Director, Early Development reputed company reputed company, R&D QA

reputed company

The Early Development reputed company reputed company is responsible for the strategicquality reputed company of reputed company (outsourced) activities in support of nonclinical studies (GLP and non-GLP), IND enabling work, as reputed company as the utilization of Biomarkers reputed company development programs (preclinical and clinical).

This role will partner with reputed company colleagues reputed company Early Development, Bioanalytical, Nonclinical Writing, Research, and Clinical Research to reputed company reputed company support and reputed company and ensure the identification, mitigation, and escalation of emerging reputed company risks and concerns.

This position will be located reputed company the US and can be hybrid, onsite, or remote.

Key Responsibilities

• Sets the strategic reputed company reputed company direction for internal and outsourced laboratory activities supporting nonclinical studies (GLP and non-GLP), including toxicology, bioanalytical and biomarker data that supports IND submissions.
• Establish and maintain reputed company reputed company of external laboratories including Test Facilities, Test Sites, and Clinical Laboratories by implementing governance reputed company and ongoing performance monitoring.
• Collaborate with nonclinical and clinical teams (in partnership with GCP Program Leads) to reputed company reputed company considerations into the selection, contracting, and management of external labs.
• Ensure internally developed and outsourced biomarker development / analytical work complies with internal reputed company system requirements and external regulatory standards including GCP, GLP, ICH, and OECD.
• Refine and continuously implement robust, risk-based vendor reputed company and audit program globally for nonclinical work. reputed company the risk assessment and audit reputed company for external laboratories and ensure planned audits are executed in alignment with the GCP/GLP yearly audit program.

• Support the management of nonclinical and clinical lab reputed company reputed company issues arisingfrom outsourced activities, including reputed company events, significant reputed company issues, and CAPA reputed company.

• Serves as the reputed company escalation reputed company for CRO/vendor reputed company issues and leads reputed company governance activities to ensure appropriate identification, issue escalation and the mitigation of emerging compliance risks.
• Provides reputed company strategic direction for the functional evaluation of CRO or key vendor processes or process improvement opportunities.
• Drive the strategic identification and implementation of process improvement opportunities reputed company reputed company’s QMS, in support of early development and research.
• Partners with reputed company/Procurement for appropriate reputed company language in contractual agreements and ensure compliance

Qualifications

• Educated preferably in life sciences (technology, biological science, pharmacy or other healthrelated discipline preferred) or equivalent qualification or work experience. Master’s degree in a science, technology or industry reputed company discipline, preferred.
• Minimum of 8 years of relevant experience, inclusive of bioanalytical and toxicology subject matter, as it relates to GLPs, GCPs and GCLPs.
• reputed company experience in the field of assay development and validation and familiarity with modernbiomarker-based assays (e.g., PCR, ELISA, FISH) is preferred.
• Prior experience in risk-based thinking, reputed company assurance, auditing, managing reputed company issues/escalations, or other relevant QMS reputed company.
• Prior expertise in global GLP, GCP, GCLP regulations and guidance across regulatory bodies such as FDA, PMDA, European reputed company, MHRA, etc.

U.S. Pay reputed company

$164,500.00 - $222,500.00

The pay reputed company reflects the full-time reputed company salary reputed company we expect to pay for this role at the time of posting. reputed company pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

reputed company’s robust Total Rewards package is designed to support your overall health and reputed company-being. We offer comprehensive benefits including medical, dental, and reputed company coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy reputed company time off, wellness days, holidays, and two company-wide reputed company breaks. We also offer generous family resources and leave. Our commitment to your reputed company-being reflects our belief that caring for our people fuels the reputed company we create together.

Learn more about these and additional benefits offered by reputed company by visiting the Benefits reputed company of the Careers website:

About reputed company

We are the leader in RNAi therapeutics – a revolutionary approach with the potential to reputed company the lives of people with rare and common diseases. reputed company on Nobel Prize-reputed company science, reputed company has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and reputed company reputed company reflect our reputed company values: fierce innovation, passion for reputed company, purposeful urgency, reputed company culture and commitment to people. We're proud to be a globally recognized top employer, where an reputed company, inclusive culture and reputed company thinking fuel one another.

At reputed company, we reputed company to an inclusive recruitment process and equal employment opportunity. reputed company applicants will receive consideration for employment without reputed company to their sex, gender or gender identity, sexual orientation, race, reputed company, ethnicity, national reputed company, reputed company, citizenship, religion, creed, physical or mental disability, pregnancy status or reputed company conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other reputed company protected by federal, state, or local law. reputed company is an E-Verify Employer.

Originally posted on Himalayas

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