Specialist - Quality Operations

Reposted 10 Hours Ago
Be an Early Applicant
Hiring Remotely in Office, Machaze, Manica, MOZ
Remote
Senior level
Biotech • Pharmaceutical
The Role
Manage end-to-end supplier/vendor quality activities including drafting QA agreements and annual monitoring reports, handling supplier change notifications, supplier qualification, QRA, audit and CAPA support, regulatory statement preparation, and coordination with SIM/TPRM and stakeholders for supplier quality deliverables.
Summary Generated by Built In

Job Description Summary

End to End Supplier / Vendor Quality Management Activities


 

Job Description

Supplier Quality Management:

•        Drafting / Authoring of Annual Monitoring and Certification report for incoming materials.

•        Drafting / Negotiation (if applicable) and Archival of Quality Assurance Agreement with

Suppliers/Service providers.

•        Evaluation and Management of Supplier Change Notifications (SCN) and Initiation of quality

record for the applicable SCN.

•        Drafting and Evaluation of Supplier’s incoming materials Specification.

•        Performing Quality Risk Assessment (QRA) for existing and new Suppliers / Service providers.

•        Management of Supplier/ Material qualification and supplier related documentation.

•        Preparation of regulatory statement for materials and finished products.

•        Management Quality records, Support the Service Delivery team (SDT) with quality topics and 3rdPAP Management in TPRM (Third Party Risk Management) tool.

•        Co-ordination with stakeholders in SIM (Supplier Information Management) approval process for Quality deliverables.

•        Preparation of relevant contributing report for respective APQR section.

•        Evaluation of change control tasks/ deviations related to supplier quality management.

•        Coordination in handling Discrepant Materials.

•        Audit preparation support, QARP and FURP Role for audit and CAPA Management.

•        Responsible for the Functional representative activities.

•        End to end deliverables for supplier quality management activities as per the delegated task from the business partner.

Preferable Experience - Around 8 Years

Education - M Pharma / B Pharma / MSc or Equivalent from Reputed university.

Languages:

  • English.


 

Skills Desired

Collaboration, Data Integrity, Leadership, Operational Excellence

Skills Required

  • M Pharma / B Pharma / MSc or equivalent
  • Around 8 years of relevant experience
  • Experience in supplier/vendor quality management (supplier qualification, SCN handling, QA agreements)
  • Experience with audit preparation and CAPA management
  • Experience performing Quality Risk Assessment (QRA) and contributing to APQR
  • Familiarity with Third Party Risk Management (TPRM) tools and Supplier Information Management (SIM)
  • Ability to prepare regulatory statements for materials and finished products
  • English language proficiency
  • Skills: Collaboration, Data Integrity, Leadership, Operational Excellence

Novartis Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Novartis and has not been reviewed or approved by Novartis.

  • Healthcare Strength Pay and benefits are described as a strong overall package, supported by medical, dental, and vision insurance alongside FSAs/HSAs and disability and life coverage. Mental-health support is reinforced through an employee assistance program with psychological support and a network of mental health first aiders.
  • Retirement Support Retirement support is positioned as a standout element, with an automatic company contribution plus dollar-for-dollar matching in the 401(k). Additional retirement funding is described through an age-based defined contribution program and access to an employee share purchase plan discount.
  • Parental & Family Support Family-related benefits are framed as robust, including a global minimum of paid parental leave for new parents following birth or adoption. Added supports include domestic partner coverage, dependent-care resources, and benefits such as adoption assistance and child/elder care options.

Novartis Insights

Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
HQ: Basel
110,000 Employees
Year Founded: 1996

What We Do

Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.

Similar Jobs

Auror Logo Auror

Chief Of Staff

Artificial Intelligence • Big Data • Retail • Security • Social Impact • Software • Business Intelligence
Remote or Hybrid
Office, Machaze, Manica, MOZ
212 Employees
200K-230K Annually

Clearwater Analytics (CWAN) Logo Clearwater Analytics (CWAN)

Marketing Operations Manager

Fintech • Software • Financial Services
Remote or Hybrid
3 Locations
1100 Employees
102K-144K Annually

Mondelēz International Logo Mondelēz International

Internal Controls Senior Analyst

Big Data • Food • Hardware • Machine Learning • Retail • Automation • Manufacturing
Remote or Hybrid
5 Locations
90000 Employees

Auror Logo Auror

Technical Product Manager

Artificial Intelligence • Big Data • Retail • Security • Social Impact • Software • Business Intelligence
Remote or Hybrid
Office, Machaze, Manica, MOZ
212 Employees
145K-210K Annually

Similar Companies Hiring

SOPHiA GENETICS Thumbnail
Software • Healthtech • Biotech • Big Data • Artificial Intelligence
Boston, MA
450 Employees
Pfizer Thumbnail
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
New York, NY
121990 Employees
Cencora Thumbnail
Healthtech • Logistics • Pharmaceutical
Conshohocken, PA
51000 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account