Manager, QA Compliance Supplier Quality
Company: Amplify Bio
Location: New Albany
Posted on: October 17, 2024
Job Description:
Are you passionate about significantly improving the future of
medicine? Do you believe that people are the most important asset
of any company? If so, join AmplifyBio!AmplifyBio is a leading
contract research organization with a comprehensive range of
services that span from being an outsourcing partner for discovery
stage R&D work, a preclinical CRO performing safety efficacy
and toxicology studies for small molecules and advanced therapies
alike, and, most recently, an expansion into manufacturing services
for cell, gene, and mRNA-based therapeutics.The AmplifyBio
ecosystem is comprised of three distinct business units: ADOC
(South San Francisco, CA)- Amplify's Discovery, Optimization, and
Characterization laboratories: ASET (West Jefferson, OH) -
Amplify's Safety, Efficacy, and Toxicology Site; and the most
recently opened AMEC (New Albany, OH) - Amplify's Manufacturing
Enablement Center. About AMEC New Albany, OH: AmplifyBio's
Manufacturing Enablement Center provides customizable cGMP suites
to enable advanced therapy manufacturing in a "hoteling model,"
traditional contract development and manufacturing (CDMO) or a
hybrid model. Partnering with AmplifyBio for manufacturing cell
therapy, gene therapy, mRNA, plasmid, or other modality is quite
different from a typical CDMO experience. The goal is to provide
flexible solutions customized to client needs while bringing full
expert partnership. At AmplifyBio drug developers will find an
innovation-rich ecosystem designed to advance a diverse range and
class of pharmaceutical products across development
stages.AmplifyBio is seeking to hire a Manager, QA Compliance -
Supplier Quality to join our growing team!!!The Manager, QA
Compliance - Supplier Quality is responsible for the management and
the execution of the Suppler Quality Management (SQM) and Audit
Programs for the New Albany GMP facility. This role will ensure
supplier qualifications, external and internal audits are performed
in a timely manner to meet quality and business objectives. The
ideal candidate will be a hands-on leader with experience building
and maintaining supplier quality and raw material programs in GMP
regulated environments.What You'll Do Here:
- Develop and/or enhance existing procedures for: the selection
and management of GMP suppliers, qualification of raw materials
(with QC Bioanalytics), and the execution of the audit program
(internal, external and client audits).
- Maintain GMP vendor files, Approved Supplier List (ASL) and
conduct periodic assessment to ensure all vendor certification
documents, licenses, and statements are current.
- Draft quality technical agreements as required.
- Co-manage the Material Review Board with QA Ops
leadership.
- Manage the supplier and internal audit schedule, generate audit
plans and conduct routine quality audits of GMP suppliers / service
providers and internal QMS.
- Maintain all audit reports, audit responses, and pertinent
corrective actions up to date.
- Conduct follow-ups for internal and supplier audits corrective
actions to ensure closure.
- Support QA Operations team to investigate product quality
complaints, quality events, incidents and CAPAs associated with
materials or supplier services.
- Develop and report KPIs for SQM and the audit program, assist
Supply Chain with KPIs related to material qualification and
release.
- Work with QA Training Admin to expand and perform site training
for the supplier and audit programs to ensure process alignment.We
Would Love to Hear from You If:
- A bachelor's degree or higher in a relevant scientific
discipline - Bioinformatics, Biology, Biochemistry, Chemistry or
equivalent education and experience.
- A minimum 6 years of experience in Quality within a GxP
biotechnology or pharmaceutical environment.
- Must have documented experience with Supplier Quality
Management and Internal/External Auditing. SQM and/or CQA
certifications are a plus.
- Ability to apply GMP regulation and guidelines related to
supplier management, such as, 21 CFR Part 210 and 211.
- Ability to work with minimal supervision.
- Experience managing a team of direct reports.
- Strong interpersonal skills, ability to work in a team
environment, attention to details and excellent problem resolutions
skills.
- Ability to apply a risk-based approach related to this role.At
AmplifyBio, we're committed to growing and empowering an inclusive
community within our company and industry. Therefore, we hire and
cultivate diverse teams of the best and brightest from all
backgrounds, experiences, and perspectives across our
organization.AmplifyBio is an equal opportunity employer, and we
value diversity at our company. We don't discriminate on the basis
of race, color, citizenship status, national origin, ancestry,
gender (including gender expression and gender identity), sexual
orientation, age, weight, religion, creed, physical or mental
disability, marital status, veteran status, political affiliation,
or any other factor protected by federal, state, or local law.Why
You Will Love Working Here:We take the health and happiness of our
employees seriously and consistently evaluate new ways to Amp up
our benefits to provide an amazing place to work. From a wellness
program to financial planning and legal assistance, we make sure to
take care of our own.
- Health, Dental, and Vision insurance that starts on your first
day at AmplifyBio!
- Competitive Compensation Package
- We take work-life balance seriously and we back it up with a
FLEXIBLE PTO policy.
- Generous paid parental leave
- Wellness and Self-Care Programs
- 401(k) match
- Tuition Reimbursement
- EAP/work-life support system
- A fun work environment where everyone's voice matters.
- We are just getting started! More benefits on the way!
- An Opportunity to Change the World!!!When you join our team,
you will be a part of groundbreaking work while collaborating with
our clients, research scientists, study directors, lab technicians,
and specialists across a variety of disciplines. The future for
AmplifyBio is as great as the combination of our imaginations and
actions, and we hold ourselves accountable for our choices and
results. We have a bias for action, excellence, and, especially,
the health and safety of our employees.
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Keywords: Amplify Bio, Elyria , Manager, QA Compliance Supplier Quality, Executive , New Albany, Ohio
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