Easter Seals Jobs

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

#LI-AB1

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)

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.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled