Head of Quality

Vor 3 Tagen

Dresden, Deutschland PCI Pharma Services Vollzeit

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Special Competences:

- Management of the Quality Assurance, Quality Systems, Qualified Persons, and Quality Control areas at the site, in line with corporate strategy and within regulatory requirements.
- Part of the Senior Leadership Team at the PCI Berlin site.

Job Objectives:

- Leads and develops a strong quality culture, empowering the team, leading by example and placing responsibility at the right level within the organisation.
- Manages and motivates a high performing team.
- Determines and drives site Quality Metrics in line with Corporate and Site goals.
- Ensures that products are packaged and controlled to meet required safety, quality and GMP standards.
- Ensures that a system is in place for the following:

- All components for production are issued to production on time and in the prescribed manner.
- Reviews completed documentation.
- Tracks and monitors documentation throughput times.
- Quality Key Performance Indicators (KPIs) are established, measured, and maintained and are in line with company objectives.
- Acts as the main point of contact for quality related matters at the PCI Berlin site.
- Acts as main contact person customers and auditors (e.g., of the responsible health authority).
- Leads the Quality department of PCI Berlin (QA, QP & QC).

Description of tasks:

- Ensures that a team is in place to maintain complaint management focused on handling complaints, change controls, deviations and CAPA.
- Maintains, guides, and supports the various elements of quality management including audits, training, SOPs, documentation, change controls, complaints, investigations and CAPAs to ensure ongoing compliance with customer, regulatory and internal requirements.
- Provides bi-annual reports to senior management (Quality Management Review, QMR).
- Develops and monitors the annual budget for the quality department.
- Ensures all process documentation is fully auditable, i.e., created, updated, and filed in accordance with all regulatory expectations.
- Ensures a system is in place for a robust audit management system for both internal and external audits.
- Develops and maintains a culture of continuous improvement by actively implementing process excellence and lean methodologies.
- Actively promotes best practices for quality management improvement and continuous improvement and problem solving at the
- Leads benchmarking of processes and quality systems.
- Leads project management to ensure effective planning and timely execution of all processes.
- Any other duties assigned by supervisor.

Specification:

- Business or science degree or equivalent qualification.
- Several years of experience in a similar role with demonstrable experience, preferably as a manager
- Knowledge of GMP and GDP regulations.
- Experience in operating ERP systems, ideally JDE (Oracle).
- High level knowledge of packaging equipment, facilities, and processes.
- To have good knowledge of Quality Assurance inspection requirements.
- Good working knowledge of cGMP
- QMS Experience
- Risk Analysis and Associated Methodology
- Knowledge of ICH, GAMPs, Annex 11 and Eurdalex guidelines
- Fluent in business German and English
- Very good Interpersonal skills
- Good written communication skills
- Technical aptitude
- Embracing company vision and values
- Analytical approach / attention to detail
- Excellent organisational, planning and management skills
- Excellent team player with strong leadership skills. Ability to build working relationships with stakeholders
- High flexibility to adapt, react quickly and deal with change in a fast-paced environment
- Self-motivated and organised
- Persuasive
- Pragmatic, solution-oriented person with positive energy, tenacity and resilience

Join us and be part of building the bridge between life changing therapies and patients.

Let’s talk future

Equal Employment Opportunity (EEO) Statement:

- PCI Pharma Services is an Equal_
- Opportunity/Affirmative_
- Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._

  • Head of Quality

    vor 7 Monaten

    Dresden, Deutschland PCI Pharma Services Vollzeit

    Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Main Responsabilities: - Management of the...

  • Head of Life Cycle Management

    vor 7 Monaten

    Dresden, Deutschland Oncotec Pharma Produktion GmbH Vollzeit

    Head of Life Cycle Management (m/w/d) **Ihre Arbeitsaufgaben**: - Jeden Tag fertigt die Oncotec lebensrettende Medikamente. Als Head of Life Cycle Management übernehmen Sie Verantwortung im Bereich Quality für ein kleines Team, welches den Lebenszyklus dieser Produkte begleitet. - Mit Abschluss der Prozessvalidierung übernimmt das Team die Produkte,...

  • Head of Cost Estimation

    Vor 3 Tagen

    Dresden, Deutschland Linde GmbH, Linde Engineering Vollzeit

    Linde GmbH, Linde Engineering **Head of Cost Estimation & Product Management (M/F/d)** Dresden, Germany｜req11361 **What you will enjoy doing** - As the Head of Cost Estimation & Product Management at Linde Engineering Dresden, you will be responsible for leading and managing the cost estimation and product management teams - You will play a key role in...

  • Interim Head of Accounting

    vor 6 Monaten

    Dresden, Deutschland CeoLiebling GmbH Vollzeit

    Wir suchen einen Interim Head of Accounting 70% vor Ort in Sachsen, Rest remote **Laufzeit**: 6 Monate, attraktive Vergütung und Aufgabenstellung **Start**: spätestens 11.03.24 Aufgaben - Führung der Mitarbeiter - Begleitung Jahresabschluss - und Konzernprüfung - Abbearbeitung der USt. Themen - Ansprechpartner WP und Tochtergesellschaften -...

  • Head of Product M/w/d

    vor 6 Monaten

    Dresden, Deutschland SQL Projekt AG Vollzeit

    Head of Product m/w/d **We empower organizations** **to focus on what matters! **Alles andere übernimmt unsere Low-Code-Plattform TRANSCONNECT®. TRANSCONNECT® ist unsere Integrationsplattform, die darauf ausgerichtet ist, Klarheit in die komplexen IT-Landschaften unserer Kunden zu bringen und die nahtlose Integration von Daten und Geschäftsprozessen zu...

  • Head of Brr

    vor 7 Monaten

    Dresden, Deutschland Triga Consulting GmbH & Co KG Vollzeit

    Für unseren Kunden ein deutsches, international erfolgreiches Unternehmen mit Spezialisierung im Pharmabereich - suchen wir derzeit Sie als Head of BRR & Qualified Person (m/w/d) Aufgaben - Sachkundige Person gemäß - 15 AMG zur routinemäßigen Freigabe von Bulkwaren und Fertigarzneimitteln - Durchsetzung der GMP-Regeln in allen GMP relevanten...

  • Leiter Instandhaltung

    vor 7 Monaten

    Dresden, Deutschland GLOBKON GmbH Vollzeit

    **Wir suchen aktuell: Leiter Instandhaltung / Head of Maintenance (m/w/d) in Dresden**: **Leiter Instandhaltung / Head of Maintenance (m/w/d) in 01067 Dresden**: Für unseren erfolgreichen und stetig expandierenden internationalen Kunden (20 000 Mitarbeiter weltweit) mit langjähriger Tradition auf dem Markt suchen wir für sein modernes Werk in der Nähe...

  • Head of Regulatory Affairs

    vor 2 Monaten

    Dresden, Deutschland Arevipharma GmbH Vollzeit

    Die Arevipharma GmbH ist ein moderner Hersteller pharmazeutischer Wirkstoffe und Zwischenprodukte mit einer nahezu 150-jährigen Tradition. Zu unseren Kunden zählen generische und forschende Pharmaunternehmen auf fünf Kontinenten.Für unser Regulatory Affairs Team suchen wir einen Head of Regulatory Affairs (m/w/d)APCT1_DE

  • Head of Professional Services M/w/d

    vor 7 Monaten

    Dresden, Deutschland SQL Projekt AG Vollzeit

    Head of Professional Services m/w/d Als 'Head of Professional Services' spielst du eine zentrale Rolle in unserem Professional Services Team, das Unternehmen dabei unterstützt, die volle Leistungsfähigkeit unserer Integrationsplattform TRANSCONNECT® auszuschöpfen. In deiner Rolle als Head of Professional Services leitest du ein Team von Expert:innen und...

  • Head of Projektmanagement

    vor 7 Monaten

    Dresden, Deutschland ITC AG Vollzeit

    Die **SBU - Sächsische Baustoffunion **sucht zum nächstmöglichen Zeitpunkt einen **Head of Projektmanagement** (m/w/d). Die SBU ist Teil eines Konzerns und übernimmt in ihrer Rolle auch für verbundene Unternehmen wie die ITC AG kaufmännische und organisatorische Aufgaben und Projekte. In dieser verantwortungsvollen und vielseitigen Position sind Sie...

  • Head of Talent Acquisition

    Vor 3 Tagen

    Dresden, Deutschland Wandelbots GmbH Vollzeit

    **Your mission**: - You lead, inspire and manage a talented TA Team as well as train and educate them on high quality standards and best practices - You conduct our recruiting and sourcing strategies to find real top talents - You are hiring the C-level leadership - You prepare and review our annual recruitment budget - You manage our external partnerships...

  • Head of Supplier and Audits

    vor 6 Monaten

    Dresden, Deutschland Merz Pharma GmbH Co. KGaA Vollzeit

    Die führenden Positionen auf den Märkten der Welt unserer Geschäfte Merz Aesthetics, Merz Therapeutics und Merz Consumer Care sind das Ergebnis unseres Innovationsgeistes - und des Engagements unserer Mitarbeiter. Ein hochattraktives Portfolio, eine starke Strategieausrichtung und Dynamik machen uns zu einem Unternehmen, das auf langfristigen Wachstum und...

  • Working Student in The Area of Line Quality

    vor 7 Monaten

    Dresden, Deutschland GLOBALFOUNDRIES Vollzeit

    **About GF** GlobalFoundries® Inc. (GF®) is one of the world's leading semiconductor manufacturers. GF redefines innovation and semiconductor manufacturing by developing and delivering feature-rich process technology solutions with leading performance in all growth markets. GF offers a unique mix of design, development and manufacturing services. With a...

  • Quality Management Officer

    vor 7 Monaten

    Dresden, Deutschland Headhunt Vietnam Vollzeit

    Organization and implementation of HACCP team meetings - Processing and evaluating complaints, evaluating returns - External representation of the company in the area of quality assurance and quality management - Responsible for the implementation of food law regulations - Participation and technical guidance in the planning and implementation of the...

  • Head of Project Management

    Vor 3 Tagen

    Dresden, Deutschland Linde GmbH, Linde Engineering Vollzeit

    Linde GmbH, Linde Engineering **Head of Project Management (M/F/d)** Dresden, Germany｜req11045 **What you will enjoy doing** - As Head of Project Management you have full responsibility for personnel and project results - You manage and supervise project related tasks including planning, coordination and control of schedule, cost and HSE for all...

  • Head of Facility Management

    vor 3 Wochen

    Dresden, Deutschland Sunfire Vollzeit

    â®â¯Head of Facility Management - Divisionsleitung / Bauprojekte / TGA (w/m/d) Über das Unternehmen Wir brennen für das, was wir tun. Unsere Vision: Die Welt von fossilen Brennstoffen befreien. Mit unseren innovativen Wasserstofftechnologien helfen wir großen Industrieun...

  • Head of Permanent Placement

    vor 7 Monaten

    Dresden, Deutschland AC Personalservice Personalvermittlung & -beratung Vollzeit

    +++ AC Personalservice +++ kompetente Direktvermittlung +++ Für Sie kostenfrei +++ **Wir suchen ab sofort: Head of permanent placement (m/w/d) Personalvermittlung in 01067 Dresden**: Als Partner renommierter Dienstleistungsunternehmen sind wir immer auf der Suche nach qualifizierten Personen und kreativen Talenten. Im Rahmen der Vermittlung in eine...

  • Head of Permanent Placement

    vor 7 Monaten

    Dresden, Deutschland AC Personalservice Vollzeit

    **Head of permanent placement (m/w/d) Personalvermittlung in 01067 Dresden**: Als Partner renommierter Dienstleistungsunternehmen sind wir immer auf der Suche nach qualifizierten Personen und kreativen Talenten. Im Rahmen der Vermittlung in eine Festanstellung suchen wir für einen unserer renommierten Kunden aus der Personaldienstleistungsbranche für die...

  • Global Head of Sales

    vor 7 Monaten

    Dresden, Deutschland Wandelbots GmbH Vollzeit

    **Your mission**: Wandelbots is a groundbreaking deep tech software start up, revolutionizing industrial automation with a robot-agnostic software stack. Our focus is on user-friendliness and bridging the IT-OT gaps, helping our clients to achieve enhanced efficiency and significant cost savings. As Global Head of Sales, you will be at the forefront of...

  • Global Head of Sales

    vor 7 Monaten

    Dresden, Deutschland Wandelbots GmbH Vollzeit

    **Your mission**: Wandelbots is a groundbreaking deep tech software start up, revolutionizing industrial automation with a robot-agnostic software stack. Our focus is on user-friendliness and bridging the IT-OT gaps, helping our clients to achieve enhanced efficiency and significant cost savings. As Global Head of Sales, you will be at the forefront of...