Talent.com
Alnylam Pharmaceuticals
Associate Director, Early Development Quality Lead, R&D QAAlnylam Pharmaceuticals • Cambridge, MA, United States
No longer accepting applications
Associate Director, Early Development Quality Lead, R&D QA

Associate Director, Early Development Quality Lead, R&D QA

Alnylam Pharmaceuticals • Cambridge, MA, United States
13 days ago
Salary
$164,500.00–$222,500.00 yearly
Job type
  • Full-time
Job description

Associate Director, Early Development Quality Lead, R&D QA

The Early Development Quality Lead is responsible for the strategic quality oversight of internal and external (outsourced) activities in support of nonclinical studies (GLP and non-GLP), IND enabling work, as well as the utilization of Biomarkers within development programs (preclinical and clinical). This role will partner with Alnylam colleagues within Early Development, Bioanalytical, Nonclinical Writing, Research, and Clinical Research to provide quality support and oversight and ensure the identification, mitigation, and escalation of emerging quality risks and concerns. This position will be located within the US and can be hybrid, onsite, or remote.

Key Responsibilities:

  • Sets the strategic quality oversight 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 quality oversight of external laboratories including Test Facilities, Test Sites, and Clinical Laboratories by implementing governance framework and ongoing performance monitoring.
  • Collaborate with nonclinical and clinical teams (in partnership with GCP Program Leads) to integrate quality considerations into the selection, contracting, and management of external labs.
  • Ensure internally developed and outsourced biomarker development / analytical work complies with internal quality system requirements and external regulatory standards including GCP, GLP, ICH, and OECD.
  • Refine and continuously implement robust, risk-based vendor oversight and audit program globally for nonclinical work.
  • Lead the risk assessment and audit strategy 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 focused quality issues arising from outsourced activities, including quality events, significant quality issues, and CAPA oversight.
  • Serves as the Quality escalation point for CRO/vendor quality issues and leads quality governance activities to ensure appropriate identification, issue escalation and the mitigation of emerging compliance risks.
  • Provides quality 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 within Alnylam's QMS, in support of early development and research.

Qualifications:

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

U.S. Pay Range $164,500.00 - $222,500.00

Create a job alert for this search

Associate Director, Early Development Quality Lead, R&D QA • Cambridge, MA, United States

Similar jobs

Purchasing & Procurement AD (Strategic Sourcing Associate Director) - Hybrid (ET)

Wolters KluwerBoston, MA, United States
Full-time

Purchasing & Procurement AD (Strategic Sourcing Associate Director) “ Hybrid (ET) R0054614 GBS Sourcing - Wolters KluwerAbout the RoleAs a Purchasing & Procurement ... Show more

 • Promoted

Associate Director, Contracts (Onsite)

RaytheonAndover, MA, United States
Full-time

At Raytheon, the foundation of everything we do is rooted in our values and a higher calling to help our nation and allies defend freedoms and deter aggression.We bring the strength of more than 1... Show more

 • Promoted

Associate Director - Odyssey Technical Center

Odyssey SystemsWakefield, MA, United States
Full-time

Associate Director, Technical Center.We are seeking a forward-leaning Associate Director, Technical Center to lead the coordination, operations, and growth of Odyssey's technical capabilities.This ... Show more

 • Promoted

Consumer Research Associate (Remote)

GL IncBrockton, Massachusetts
$15.00 hourly
Remote
Part-time +1

Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies.We guarantee 15-25 hours per week with an hourly pay of bet... Show more

 • Promoted

Associate Director, Quality Control (56861)

Praxis Precision Medicines, IncBoston, MA, United States
Full-time

Associate Director, Quality Control.Fully Remote Remote - Boston, MA 02110.Position Type Full Time Education Level 4 Year Degree Travel Percentage Minimum of 2x/year to Boston area Category Biotec... Show more

 • Promoted

New Product Development / R&D Director

BYRNA TECHNOLOGIES INCAndover, MA, United States
Full-time

Lead New Product Management for mechanical and electro-mechanical hardware, overseeing product lifecycles from design through manufacturing and integrating IoT capabilities.Drive hands-on mechanica... Show more

 • Promoted

Associate Director, GMP QA

Formation Bio (Formerly TrailSpark)Boston, MA, United States
Full-time

Associate Director, GMP QAFormation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development.Advancements in AI and drug discovery are creating more ca... Show more

 • Promoted

Associate Director - Technology Ventures

Northeastern UniversityBoston, MA, United States
Temporary

Associate Director Of Tech Ventures.The primary responsibility of the role of Associate Director of Tech Ventures is to identify and nurture promising technologies and teams ripe for commercializat... Show more

 • Promoted

Associate Director, Analytics and Operations

ReplimuneWoburn, MA, United States
Full-time

Replimune's mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient's ... Show more

 • Promoted

Associate Director - Business Development

Eclipse Recruiting SolutionsBoston, MA, United States
Full-time

Business Development Professional.Siegfried is adding Business Development professionals to its National Market Sales Team (NMST).This position offers the opportunity to be an ambitious, well-conne... Show more

 • Promoted

Associate Director, Global Quality Risk Management

BiogenCambridge, MA, United States
Full-time

Associate Director, Global Quality Risk Management.As the Associate Director, Global Quality Risk Management, you will be at the forefront of Biogen's commitment to quality excellence.Leading the c... Show more

 • Promoted

Associate Director of Business Development - Northeast US (Biotech Services)

CoriolisBoston, MA, United States
Full-time

Business Development Manager (F/M/D) - Northeast US.As Business Development Manager (f/m/d) - Northeast US, you will be based in the Greater Boston area, one of the world's leading biotechnology an... Show more

 • Promoted

Associate Director, Data Quality & EDC UAT Lead - Remote

Takeda PharmaceuticalsBoston, MA, United States
Remote
Full-time

A leading pharmaceutical company in Boston is looking for a dynamic candidate to lead user acceptance testing for electronic data capture systems.The role involves creating detailed test plans, col... Show more

 • Promoted

Director, Clinical Quality Assurance

Seaport TherapeuticsBoston, MA, United States
Full-time

Director, Clinical Quality Assurance.Seaport Therapeutics is a clinical-stage therapeutics company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs... Show more

 • Promoted

Associate Director, Technology

Wellington ManagementBoston, MA, United States
Full-time

Associate Director for Technology.The Associate Director for Technology will work will serve as a strategic partner and trusted advisor to the firm's Chief Technology Officer to achieve business ou... Show more

 • Promoted

Associate Director, Precision

Digitas North AmericaBoston, MA, United States
Full-time

Digitas is the Networked Experience Agency, built on the vision that we create magnetic experiences that earn the right for brands to exist in human networks.We deliver Networked Experiences by lev... Show more

 • Promoted • New!

Associate Director, GCP/GVP Supplier Quality

Takeda Pharmaceutical Company LtdBoston, MA, United States
Full-time

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Taked... Show more

 • Promoted

Associate Director Business Development Search and Evaluation (Oncology)

LG ChemBoston, MA, United States
Full-time

Associate Director Of Search & Evaluation.LG Chem Life Sciences USA is looking for an Associate Director of Search & Evaluation to be a key driver in LG/AVEO's oncology external research and innova... Show more

 • Promoted

Associate Director Physics Team Leader and Process Automation

NovartisCambridge, MA, United States
Full-time

Associate Director Physics & Process Automation Team Leader.Location: Watertown, MA (not remote, requires 20% travel).We are looking for experience in physical irradiation technologies and related ... Show more

 • Promoted

Remote-Eligible External Manufacturing Associate Director

Vertex Pharmaceuticals (San Diego) LLCBoston, MA, United States
Remote
Full-time

A leading biopharmaceutical company is seeking an Associate Director of External Manufacturing to oversee Contract Manufacturing Organizations (CMOs) for cell and gene therapy solutions.This role w... Show more