Senior Auditor, Supplier Quality
Company: Rocket Pharmaceuticals
Location: Cranbury
Posted on: January 26, 2023
|
|
Job Description:
Work at ROCKET PHARMA and help cure rare diseases!Rocket Pharma
is a fully integrated, clinical-stage company advancing gene
therapies with curative potential for multiple rare childhood
diseases. Rocket places enormous value on people and considers team
member progress and well-being to be as important as the progress
of its pipeline. We are looking for hands-on team players who enjoy
collaborating with colleagues. We share a passion for seeking gene
therapy cures for devastating diseases and making a difference for
patients. This is an opportunity to become an integral part of a
small, highly productive team and to help grow an entrepreneurial,
scientifically driven organization that is increasingly recognized
as a leading biotechnology innovator. In addition to a competitive
compensation package featuring a generous 401K match and stock
options, the position includes excellent health benefits.We are
seeking a motivated Sr. Auditor, Supplier Quality who will perform
audits to assure the quality of products, raw materials, services,
and data provided to Rocket by raw material suppliers, service
providers, clinical trial sites, and contract development and
manufacturing organizations (CDMOs). This is a key role in the
continued expansion of Rocket Pharma's GMP operations, providing
our professionals with the understanding and tools they need to
achieve our high standards of quality and compliance. Curiosity,
positivity, and goal-orientation are key success factors for this
role.Responsibilities:Develop risk- and performance-based audit
plans, agendas, and questionnaires. Perform on-site and remote GxP
compliance audits of GxP service providers and contract
manufacturing, testing, and clinical trial sites and
locations.Maintain an up-to-date view of supplier qualification
status through Rocket's Enterprise Resource Planning (ERP) and
electronic Quality Management Systems, maintaining all audit plans,
findings, reports, and follow-up audits and activities.Prepare
supplier performance metrics and reports to inform Senior
Management of compliance and business risks.Ensure Quality
Agreements and other technical and legal arrangements with
suppliers are clear, comprehensive, and enforced.Assist suppliers
in Quality Risk Management activities, including deviation
investigations, change management to ensure compliance with
regulatory commitments and requirements.Conduct reviews of
documents and supporting records from client organizations,
including batch records, quality control testing records,
protocols, reports, and other documentation, elevating and
resolving questions and discrepancies with the supplier.Support an
environment of continuous improvement with an emphasis on
relationship management, shared accountability, and open
communication.Actively promote data governance best practices and
work actively across the supplier network to adopt quality plans or
related strategies to ensure data integrity in all Rocket-sponsored
activities.Assist with regulatory inspections and inspection
readiness activities.As required, independently plan, conduct,
lead, and/or participate in internal audits.Benchmark to ensure
processes, systems, and Rocket Quality Standards are consistent
with current GxP and industry best
practices.Requirements:Bachelor's Degree in Life Sciences or
Engineering or equivalent relevant career experience.8+ years of
relevant GMP experience in pharma/biotech company, with at least 5+
years of experience leading and facilitating audits and 1+ year
managing a supplier quality program.Knowledge of Biologics, Cell
Therapy and/or Gene Therapy, with hands-on manufacturing or testing
experience a plus.Well versed in cGMP/ICH/FDA/EU regulations and
guidelines.Proficient in using Microsoft applications (MS Word, MS
Excel, MS PowerPoint).Must be able to correctly identify and
prioritize risk in the context of patient safety and
compliance.Detail-oriented with expert knowledge of cGMP
regulations, as well as ATMP regulations, and the ability to use
this knowledge to determine appropriate remediation
strategies.Ability to make independent and objective decisions, and
to work with minimal supervision.Must possess an independent
mindset and tenacity.Proficiency in developing reports and
presentations to facilitate meaningful discussions, with clearly
communicated analysis, findings, and impact.Ability to work
effectively across functional groups and teams to ensure
requirements and timelines are met.Excellent verbal and
communication skillsTravel Requirements - 30-40% domestic and
international travelA diverse workforce fosters innovation and
strengthens Rocket's business. We ensure equal opportunity without
discrimination or harassment in the workplace on the basis of
gender, race, color, religion, national origin, age, physical or
mental disability, pregnancy, citizenship, status as a protected
veteran, marital status, sexual orientation, gender identity and
expression, genetic information, or any other characteristic
protected by applicable local, state, and federal laws.Full
COVID-19 vaccination is required for employment at Rocket
Pharmaceuticals.
Keywords: Rocket Pharmaceuticals, Trenton , Senior Auditor, Supplier Quality, Accounting, Auditing , Cranbury, New Jersey
Click
here to apply!
|