Head of Quality - Dresden, Deutschland - PCI Pharma Services

PCI Pharma Services

Geprüftes Unternehmen

Dresden, Deutschland

vor 3 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

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 Quality Assurance, Quality Systems, Qualified Persons, and Quality Control areas at the site, in line with corporate strategy and within regulatory requirements.
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.
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).
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.

Requirements:

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.
QMS Experience
Risk Analysis and Associated Methodology
Knowledge of ICH, GAMPs, Annex 11 and Eurdalex guidelines
Fluent in business German and English
Excellent team player with proven leadership experience

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._