Third Party Manufacturer and Technical Transfer QA Manager- EMEA at Abbott

Weesp, North Holland, Netherlands

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Expertise in TPM (Third Party Manufacturer) Management and Product Transfer and Technical Support
Ability to ensure cGMP and other applicable regulatory standards are met for safe, efficacious, and quality products
Experience developing Quality Improvement Plans for TPM remediations
Skills in monitoring quality performance and ensuring adherence to Quality Technical Agreements
Capability to lead Quality Technical Agreements approval and periodic review
Proficiency as primary contact for TPM Quality issues communication
Knowledge in providing QA support for investigations, trends, complaints, CAPA, validation support, and product release
Experience maintaining TPM Approved Supplier Listing
Ability to support Quality Compliance and improvement initiatives, including new contract manufacturing site approvals
Skills in analyzing data, making decisions, and providing recommendations on quality issues and crises
Cross-functional collaboration experience across EPD regions, functional areas, business units, and geographies
Ability to recommend and implement changes due to regulations or business needs
Expertise as QA Lead for Product Technology Transfer activities, including Change Control, Stability and Change Impact Assessment, Test Method Transfer, Analytical Method Validation/Verification, Process Validation/Verification, first lot quality review, and data package assembly/evaluation

Responsibilities

Provide QA support for assigned TPMs to ensure safe, efficacious, and quality product supply meeting cGMP and regulatory standards
Develop Quality Improvement Plans for TPM remediations when required
Manage TPM activities while driving continuous improvement
Monitor quality performance for assigned TPMs and ensure adherence to Quality Technical Agreements
Lead Quality Technical Agreements approval and periodic review
Serve as primary contact for communication of TPM Quality issues
Provide QA support for investigations, trends, complaints, CAPA, validation support, and product release issues
Maintain TPM Approved Supplier Listing
Support Quality Compliance and improvement initiatives
Support new contract manufacturing site approvals and approve new contract manufacturers for EPD commercial product
Act as QA Lead for investigations, trends, complaints, CAPA, validation support, product release issues, PQR review, and change control at TPM sites
Coordinate with TPMs and internal cross-functional teams for routine Quality requirements like GMP audits, new projects, or initiatives
Analyze data, make decisions or recommendations to senior staff on quality issues and crises, and resolve technical issues cross-functionally
Recommend and implement system changes due to regulations or business needs
Coordinate across functional areas, business units, and geographies to achieve impact goals
Act as QA Lead for Product Technology Transfer quality activities: initiation/implementation of Change Control/Stability and Change Impact Assessment, Test Method Transfer/Analytical Method Validation/Verification, Process Validation/Verification, first lot quality review for validation batches release, gather/evaluate Sending Unit information, and document findings

Skills

cGMP

Quality Assurance

Technical Transfer

TPM Management

Regulatory Compliance

Quality Improvement

Continuous Improvement

Risk Management

Supplier Auditing

GMP

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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