"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold t…
"Expect to grow", personnellement et professionnellement : Chez Siegfried, nous offrons des défis passionnants et de nombreuses opportunités de mettre en valeur vos talents. En tant que partenaire de confiance et respect…
"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold t…
"Expect to grow", personal y profesionalmente: En Siegfried, ofrecemos desafíos emocionantes y amplias oportunidades para demostrar tu talento. Como socio de confianza y respeto en la industria farmacéutica, mantenemos l…
Skills: Material Planning, SAP, MRP, Supply Chain Management, Microsoft Excel
Teamleitung Abweichungen, Reklamationen und Ursachenuntersuchung (jeglichen Geschlechts)
Hamelin, Lower Saxony, Germany · On-site
Mid level
"Expect to grow", persönlich und beruflich: Bei Siegfried erwarten Sie spannende Herausforderungen und zahlreiche Möglichkeiten, Ihre Talente unter Beweis zu stellen. Als ein vertrauenswürdiger und angesehener Partner de…
"Expect to grow", persönlich und beruflich: Bei Siegfried erwarten Sie spannende Herausforderungen und zahlreiche Möglichkeiten, Ihre Talente unter Beweis zu stellen. Als ein vertrauenswürdiger und angesehener Partner de…
"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold t…
Skills: IT Support, Network Technology, Microsoft Server, Active Directory, Entra ID
"Expect to grow", persönlich und beruflich: Bei Siegfried erwarten Sie spannende Herausforderungen und zahlreiche Möglichkeiten, Ihre Talente unter Beweis zu stellen. Als ein vertrauenswürdiger und angesehener Partner de…
Skills: Process Validation, CPV (Continued Process Verification), GMP Compliance, Team Leadership, Project Management
"Expect to grow", persönlich und beruflich: Bei Siegfried erwarten Sie spannende Herausforderungen und zahlreiche Möglichkeiten, Ihre Talente unter Beweis zu stellen. Als ein vertrauenswürdiger und angesehener Partner de…
"Expect to grow", persönlich und beruflich: Bei Siegfried erwarten Sie spannende Herausforderungen und zahlreiche Möglichkeiten, Ihre Talente unter Beweis zu stellen. Als ein vertrauenswürdiger und angesehener Partner de…
"Expect to grow", persönlich und beruflich: Bei Siegfried erwarten Sie spannende Herausforderungen und zahlreiche Möglichkeiten, Ihre Talente unter Beweis zu stellen. Als ein vertrauenswürdiger und angesehener Partner de…
Skills: Chemical Process Optimization, cGMP Compliance, Product Leadership, SAP Manufacturing Recipes, Multi-step Synthesis
"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold t…
Skills: Data Analytics, Data Visualization, MS Excel, MS PowerPoint, Strategic Thinking
"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold t…
Skills: SAP EWM, SAP WM, SAP S/4HANA, SAP R/3, Project Management
Laborant Wasseranalytik und Logistik (jeglichen Geschlechts)
Hamelin, Lower Saxony, Germany · On-site
Senior
"Expect to grow", persönlich und beruflich: Bei Siegfried erwarten Sie spannende Herausforderungen und zahlreiche Möglichkeiten, Ihre Talente unter Beweis zu stellen. Als ein vertrauenswürdiger und angesehener Partner de…
Skills: Water Analysis, Wet Chemistry, Instrumental Testing, SAP, Documentation
"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold t…
"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold t…
Skills: SHE Policy Development, Regulatory Compliance, Risk Assessment, ATEX Zoning, Process Safety
Director New Business Development - Northwest Region
Pennsville, New Jersey, United States · Hybrid
$158k–$197k/yr
Senior
"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold t…
Skills: New Business Development, Pharmaceutical Sales, API Manufacturing, CDMO Industry Knowledge, Market Research
Job Description Position Summary Reporting to the Revenue Manager – Billing, the Billing Specialist is responsible for ensuring that our invoices are created and sent from our system (Workday) accurately and timely. This…
Skills: Billing, Invoicing, Workday, Microsoft Excel, Data Analysis
"Expect to grow", personal y profesionalmente: En Siegfried, ofrecemos desafíos emocionantes y amplias oportunidades para demostrar tu talento. Como socio de confianza y respeto en la industria farmacéutica, mantenemos l…
Skills: SAP, Master Data Management, GMP Regulations, Microsoft Excel, Supply Chain Management
"Expect to grow", personnellement et professionnellement : Chez Siegfried, nous offrons des défis passionnants et de nombreuses opportunités de mettre en valeur vos talents. En tant que partenaire de confiance et respect…
Skills: Reaction Safety Studies, Organic Chemistry, Chemical Processes, RC1, DSC
The Quality Assurance Manager oversees all aspects of QA, including product release, regulatory inspections, and the supervision of QA/QS Specialists. They act as the primary liaison for quality decisions and drive continuous improvement of GMP compliance across the site.
Requirements
Requires a BS degree in Chemistry, Chemical Engineering, or a related technical field with 5-10 years of pharmaceutical QA experience. Candidates must have 2-5 years of leadership experience and in-depth knowledge of cGMP in a manufacturing environment.
Full job description
"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.
Your Role:
The incumbent is responsible for the management of all aspects of Quality Assurance and provides daily support and supervision to the Quality Assurance Specialists.
Your Profile:
ESSENTIAL DUTIES, RESPONSIBILITIES AND ACCOUNTABILITIES:
Project team member and primary customer contact for quality decisions and product oversight. Liaison for quality issues and execution of product release.
Executes final release of product, ensuring batches meets all quality specifications and compliance requirements. Added responsibility for on-time release.
Directs QA resources and workflow with Production and Shipping.
Sets agenda scheduling and leads audits for external customers. Authors audit responses and ensures completion of associated CAPAs.
Performs and trains QA staff on performing internal audits
Provides QA leadership during technology transfers
Integral to the management of regulatory agency inspections. Incumbent oversees flow of information, is responsible for responding to inquiries and developing strategy for risk mitigation.
Prepares and tracks KPIs for upper management.
Authors Standard Operating Procedures/Work Instructions and implements process changes.
Decision-maker of quality requirements for change controls.
Designs project scope and compliance requirements for Product and Equipment Validations, Qualifications and Assessments documents. Authors reports with scientifically sound conclusions.
Acts as the primary liaison between QA and all other departments on day-to-day basis.
Oversees the flow of logs and turnaround in the Department.
Ensures QA requirements defined in Customer Quality Agreements are met.
Acts as the primary contact for projects or issues that involve QA.
Drives continuous improvement of GMP compliance and inspection readiness
Reviews and approves change controls and ensure compliance with global change control procedures
Leads site readiness for regulatory inspections
Reviews and approves Master Production Records as appropriate.
Reviews and approves executed logs as appropriate.
Reviews and approves deviations, investigation reports and CAPAs.
Reviews and provides input to Drug Master Files (DMFs).
Manages Customer complaints, inquiries and complete requests pertaining to QA.
Participates in review and approval of all SOP’s that require QA signature.
Ensures appropriate training and GMP awareness across site personnel
Manages implementation and adherence to all applicable cGMP regulations.
Oversees Quality Systems department
Manages QA/QS budgets
Ensures Environmental Monitoring (EM) for the site is on track
Ensures that personal and departmental moral, ethical, legal, and behavioral conduct meets the Siegfried Code of Conduct.
Adheres to all applicable SHE regulations.
SUPERVISION:
The incumbent directly supervises 5 to 10 QA/QS Specialists and is responsible for staffing, performance management, and training of the direct reports.
EDUCATION AND EXPERIENCE:
-A BS degree in Chemistry, Chemical Engineering or equivalent technical field and/or 5-10 years’ experience in Quality Assurance for a pharmaceutical company
-Two to five years of leadership experience is required. In-depth knowledge of cGMP in a manufacturing environment is a must.
OTHER REQUIREMENTS:
-Must have excellent verbal and written communication skills.
-Must be able to work efficiently with people of all levels and cultures.
-Must have excellent coaching and interpersonal relationship skills.
-Must be conscientious and detail-oriented.
-Must be a team player.
-Must be a self-starter and initiator.
-Must have excellent project management skills.
Your Benefits:
Additional Benefits
Competitive performance-based bonus
Employee Share Matching Plan
401(k) Match
Medical, Dental, and Vision Offerings
Life, Sickness and Accident insurance, and Long-term disability
Increased Voluntary Life Insurance (employee and family) (optional)
The salary for this role is anticipated to be between $105,000 and $135,000
Siegfried USA will explore and provide reasonable accommodations to assist any qualified individual with a disability in performing the essential functions of his/her job. Please speak with HR should you require an accommodation or have any questions
Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 16 sites across three continents. With a team of more than 4,200 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.
Siegfried is a leading CDMO with 16 production sites on four continents. With our longstanding pharmaceutical and chemical experience, we are taking your innovations to industrial scale.
Siegfried is active in manufacturing pharmaceutical APIs (and their intermediates) as well as drug products (tablets, capsules, sterile vials, ampoules, cartridges and ointments) for the pharmaceutical industry and provides development services.
Offices: Untere Brühlstrasse 4, Zofingen, Aargau 4800, CH · Langes Feld 13, Hameln, Lower Saxony 31789, DE · Parc Industriel de la Plaine de l‘Ain, Saint Vulbas, Ain 01150, FR · Route du Simplon 1,36, Evionnaz, Valais 1902 , CH · Karlstrasse 15, Minden, North Rhine-Westphalia 32423 , DE
Siegfried is a leading CDMO with 16 production sites on four continents. With our longstanding pharmaceutical and chemical experience, we are taking your innovations to industrial scale.
Siegfried is active in manufacturing pharmaceutical APIs (and their intermediates) as well as drug products (tablets, capsules, sterile vials, ampoules, cartridges and ointments) for the pharmaceutical industry and provides development services.
Offices: Untere Brühlstrasse 4, Zofingen, Aargau 4800, CH · Langes Feld 13, Hameln, Lower Saxony 31789, DE · Parc Industriel de la Plaine de l‘Ain, Saint Vulbas, Ain 01150, FR · Route du Simplon 1,36, Evionnaz, Valais 1902 , CH · Karlstrasse 15, Minden, North Rhine-Westphalia 32423 , DE