Sr. Manager Quality Assurance

vor 9 Stunden

Zug, Schweiz Apellis Vollzeit

**Position Summary**:
The Senior Manager Quality Assurance is responsible for providing the quality oversight of routine GMP batch production activities at our Contract Service Provider (CSP) located in Switzerland.

The Senior Manager Quality Assurance will have a strong scientific background/ education which will enable him/ her to be the point of contact for the day-to-day quality assurance activities for Apellis producing intermediates and drug substance. Furthermore the individual will support the process validation activities for the second generation drug substance (GEN2). Assures products conform to regulatory requirements, company standards, and satisfies GMP regulations.

Work closely with global Quality organization and CSP partners to ensure quality events are thoroughly investigated, changes are assessed and implemented in a timely fashion and product meets Apellis' quality standards.

The position includes review and approval of Quality Management System documentation, APQR, batch record review, and batch disposition. Monitors CSP documentation for trends, identifies risks, CAPAs, and recommends remediation plans. Lead cross-functional investigations and risk assessments to resolve potential product quality issues. Plan, organize and prioritize work activities based on goals and objectives for QA.

The Sr. Manager is expected to effectively interact with external contract manufacturers, testing laboratories, packaging/labeling/distributors and other service providers, as well as work as part of an internal multidisciplinary team to support manufacturing and testing needs of commercial products globally.

**Key Responsibilities Include**:
This individual will perform and/or oversee cGMP Quality Assurance activities associated with commercial drug substance, which includes but not limited to:

- GMP Drug Substance Manufacturing Quality oversight of process and method validations, change controls, investigations, and Supplier Qualification.
- Accountable for ensuring product is dispositioned to meet Apellis' timelines for distribution
- Responsible for intermediate and drug substance batches including approval of completed manufacturing batch records, non-conformances and ensuring adequate root cause analysis and investigation activities are performed by CSPs
- Ensure conformance to specifications and GMP regulations
- Responsible to coordinate with Quality Operations and International Quality team members to support further regional product release and regulatory filing/distribution requirements.
- Responsible for providing inputs for the continuous monitoring of GMP compliance of the supply chain, including evaluation of supplier quality incidents and escalation to Senior Management as risks arise.
- Actively work with cross-functional groups and CSPs to manage receipt, review, approval and storage of documents provided by CSPs.
- Facilitate trending and evaluate of CSP documentation for CAPA and remediation
- Support continued risk-based supplier qualification program and creation or review of related Quality Technical Agreements (QTA).
- Participate in various cross-functional projects supporting continuous improvement and new programs
- Support regulatory inspections and external audits as needed
- Other duties as required.

**Accountabilities**:

- Performing deviation investigations, root cause analysis, risk assessments, investigations, CAPAs and change controls.
- Review deviations, investigations, and CAPAs associated with cGMP compliance and supports change controls related to Quality topics through knowledge of quality concepts, investigational techniques, and root cause analysis.
- Conducts Risk Assessments
- Identify and communicate quality or compliance risks and participate in determination of appropriate plan to address risks.
- Provide inputs to support continuous improvement of Quality systems and SOPs for supporting GMP activities.
- Assure Corporate Management is informed of any potential compliance issue at the Apellis facilities and contract manufacturers, testing laboratories, packaging/labeling/distributors and other service providers
- Conducts the disposition of intermediate, drug substance.

**Education, Registration & Certification**:

- BS/MS or Ph.D. in any Life Science discipline is required.
- Fluent in German and English language required

**Experience**:

- 5 years of direct Quality Assurance management experience in regulated industry (pharma/biotech and medical device)
- Strong knowledge of cGMP regulations, practices and trends pertaining to pharmaceutical product development, manufacturing, testing, and commercial operations.
- Strong technical knowledge and experience in peptide chemistry, drug substance, desired

**Skills, Knowledge & Abilities**:

- Judgment - Exhibits sound and accurate judgment; supports and explains reasoning for decisions, includes appropriate people in decision-making process, makes timely decisions
- Technical Skills - Pursues train

  • Sr. Manager Quality Assurance

    vor 9 Stunden

    Zug, Schweiz Apellis Pharmaceuticals Vollzeit

    **Position Summary**: The Senior Manager Quality Assurance is responsible for providing the quality oversight of routine GMP batch production activities at our Contract Service Provider (CSP) located in Switzerland. The Senior Manager Quality Assurance will have a strong scientific background/ education which will enable him/ her to be the point of contact...

  • Quality Assurance Manager

    vor 1 Tag

    Zug, Schweiz Viatris Vollzeit

    7087 Mylan Pharma GmbH - At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted medicines regardless of...

  • Quality Assurance Spezialist

    Vor 7 Tagen

    Zug, Schweiz ITech Consult Vollzeit

    **Quality Assurance Spezialist / Compliance Spezialist **(m/w/d) - Audits** **/** **ISO 13485 / IVD** **/ **MedTech **/ English / **German** **Projekt**: Für unseren Kunden Roche Diagnostics Schweiz International AG mit Sitz in Rotkreuz suchen wir einen **Quality Assurance Spezialist / Compliance Spezialist **(m/w/d).** Hintergrund: Der Hiring Manager ist...

  • Quality Manager

    vor 1 Tag

    Zug, Schweiz iNova Pharmaceuticals Vollzeit

    About INovaiNova is a different kind of health company. We are leading the way to better health by delivering innovative, patient-centric products that improve the lives of people around the world. Our diverse portfolio of iconic, market-leading consumer health brands and prescription medicines are backed by science and distributed in over 75 markets across...

  • Sr. Manager

    vor 1 Woche

    Zug, Schweiz Kenvue Vollzeit

    **Sr. Manager - DTO Strategy & Operations**-2307002633W Description **Senior Manager, Strategy & Operations, Digital Transformation Office** The future Kenvue organization is on a journey to become a Digital-First, independently operating business. The Digital Transformation Office (DTO) is driving the overall Digital transformation, by building and...

  • Sr Manager Biosurgery Supply Integration

    Vor 3 Tagen

    Zug, Schweiz Johnson & Johnson Vollzeit

    **_Caring for the worldone person at a time” _**inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo. **DePuy Synthes **Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the...

  • Associate, Quality Assurance

    vor 1 Tag

    Zug, Schweiz Seagen Vollzeit

    Seagen is a global multi-product biotechnology company that develops and commercializes innovative therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. In addition to four marketed products, we are...

  • Sr. Manager Deliver Risk Management

    Vor 4 Tagen

    Zug, Schweiz Johnson & Johnson Vollzeit

    Johnson & Johnson is currently recruiting a Sr. Manager, Deliver Risk Management (New Consumer Health Company). This position is located in Skillman, NJ or Zug, Switzerland with remote work options. Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science bringing...

  • Sr. Manager, Brand Communications, Popeyes, EMEA

    Vor 3 Tagen

    Zug, Schweiz 4500 PLK Europe GmbH Vollzeit

    Sr. Manager, Brand Communications, Popeyes, EMEA Apply locations Corp - Zug Corporate Office time type Full time posted on Posted 2 Days Ago job requisition id R1591 Ready to make your next big professional move? Join us on our journey to achieve our big dream of building the most loved restaurant brands in the world. Restaurant Brands International Inc. is...

  • Quality Systems Manager Mdr

    Vor 5 Tagen

    Zug, Schweiz Coopers Group AG Vollzeit

    Quality Systems Manager for Medical Devices We are seeking a Quality Systems Manager to manage the Quality Systems function for a Medical Devices fast-growing business. As the Quality Systems Manager, you will be responsible for ensuring our products comply with all relevant regulatory requirements and standards, **Responsibilities**: - Manage and...

  • Quality Assurance Engineer 80-100%

    vor 1 Woche

    Zug, Schweiz JobCourier Vollzeit

    0 km bis 30 km weit von der ausgewählten PositionSuchenSchweiz, ZugQuality Assurance Engineer 80-100%Datum der letzten Aktualisierung: 10/01/2025Überprüfen Sie Ihre Kompatibilität mit diesem StellenangebotSind Sie neugierig auf Neues? Displays sind ein faszinierendes Fachgebiet, das auf herkömmliche Weise nicht erlernt werden kann. Deshalb suchen wir...

  • Sr Director OneS4 Business Adoption EMEA

    Vor 3 Tagen

    Zug, Schweiz Kenvue Vollzeit

    Description Sr. Director, Enterprise Programs EMEA Business Adoption Lead We are recruiting for a Sr. Director, Enterprise Programs EMEA Business Adoption Lead to be focused user adoption, optimal utilization, and operations readiness across Plan, Source, Make, Deliver, Finance, Procurement and Data for the implementation of SAP S/4 HANA and the ecosystem...

  • Director Ehs, Compliance

    Vor 5 Tagen

    Zug, Schweiz Johnson & Johnson Vollzeit

    Johnson & Johnson is currently recruiting a Director EHS, Compliance & Assurance. This position may be located in Gubelstrasse, Zug, Switzerland. Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products and services to advance...

  • Sr. Manager, em Category

    vor 9 Stunden

    Zug, Schweiz Johnson & Johnson Family of Companies Vollzeit

    **Caring for the world**, one person at a time, inspires and unites Johnson & Johnson. J&J embraces research and science - bringing innovative ideas, products and services to advance health and well-being. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout...

  • Sr Manager Project Portfolio

    Vor 5 Tagen

    Zug, Schweiz Kenvue Vollzeit

    **SR Manager Project Portfolio & Controls**-2307007684W Description **Kenvue**, part of the Johnson & Johnson Family of Companies (Kenvue), is currently recruiting for **Senior Manager Project Portfolio & Controls** **Who we are** At Kenvue, part of the Johnson & Johnson Family of Companies, we believe there is extraordinary power in everyday care. Built...

  • Quality Manager

    vor 1 Tag

    Zug, Schweiz Wemedoo AG Vollzeit

    Key Responsibilities:  - Lead the development, implementation, and continuous improvement of the Quality Management System (QMS) in compliance with ISO 13485, ISO 9001, MDR, and GCP standards. - Oversee the creation, updating, and management of QMS documentation, ensuring all processes align with the latest regulatory requirements. - Drive internal audits...

  • Em Quality Category Lead

    vor 1 Tag

    Zug, Schweiz Kenvue Vollzeit

    Description **External Manufacturer Quality Category** **Leader** **Physical Location of Role**: Zug CH - The External Manufacturing (EM) Quality Category Leader is responsible for the quality oversight and coordination of activities related to the EM category. This individual is accountable for developing and leading the execution of a quality strategy...

  • Sr Manager Procurement Emea Fm Hard Services

    vor 1 Tag

    Zug, Schweiz Johnson & Johnson Vollzeit

    Johnson & Johnson is currently recruiting for a Senior Manager - CCFS Procurement FM Hard Services, EMEA located in Zug, High Wycombe, Leiden or Beerse. The Senior Manager - CCFS Procurement Facilities, EMEA will be responsible for managing the relationships of critical strategic suppliers to Johnson & Johnson Companies. This spend under management (over...

  • Quality Integration Leader

    Vor 6 Tagen

    Zug, Schweiz Johnson & Johnson Vollzeit

    Consideration for remote employees may be given on a case-by-case basis and if approved by the business. The Ethicon Surgical Care business is comprised of the following businesses within Johnson & Johnson: Ethicon Surgical Care, Ethicon Biosurgery, Ethicon Energy, Ethicon Endomechanics, Ethicon Robotics, Megadyne, NeuWave, and Torax. With annual sales of...

  • Sr. Manager Portfolio Management

    Vor 4 Tagen

    Zug, Schweiz Johnson & Johnson Vollzeit

    Johnson & Johnson is currently recruiting a Sr. Manager Portfolio Management & Strategy (New Consumer Health Company). This position is located in Skillman, NJ or Zug, Switzerland with remote work options. Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science...