Original Beschreibung
# External Site Quality Lead - Biologics (m/f/d)
**CHE - Lucerne - Tribschen (Tribschenstrasse 60)** | **Full time** | **Not Applicable**
Job Description
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.
We are currently seeking an Associate Director level (EQA) External site Quality Lead – Large Molecule Drug Product who will bring energy, knowledge, innovation and leadership to carry out the following:
* Responsibility for oversight of an External Entity (EE) involving releasing of drug substance and/or drug products for further processing with the assurance that the goods were produced or tested in conformance to all applicable policies and procedures of the company and compliance with all governing regulations.
* Responsibility for Quality Control functions including oversight for product testing, as well as other relevant components as determined by applied Calibrated Quality Oversight. These components may include review of batch documentation and deviation investigations.
* Assures the development and maintenance of a Quality Agreement with the EE. Provides input into the development of contractual agreements with the EE.
* Executes a program of Calibrated Quality Oversight based on the product type, capabilities, and quality and compliance performance of the EE.
* Ensures permanent audit readiness, regulatory inspection support and monitoring, effective complaint management, change control oversight, metric review, and review of annual product reviews. This also includes providing support to build effective quality systems at the EE and supporting continuous improvement activities.
* Oversees qualification and start-up activities by providing technical project management leadership and quality oversight for manufacture and testing of vaccine products.
* Provides support to the EE's to facilitate and validate new product introductions.
* Serves as EQA and the Manufacturing Division subject matter expert in specific Quality systems, technology platforms, regulatory expectations and/or EE management. Utilizes this expertise to drive improved and compliant processes/systems for EQA and the Manufacturing Division.
* Coordinates significant investigations including Fact Findings and product recalls as needed.
* May act as the regulatory compliance liaison on the company`s behalf to interface with regulatory agencies.
* Builds and maintains strong relationship with External Entities, as well as the Company operations, technology, analytical and procurement organizations.
* Closely collaborates with appropriate business and functional areas to conduct Tier meetings, and Joint Steering Committee meetings (as applicable) to achieve the Company objectives.
* In addition to supporting the quality operations activities at the External Entity, will support the execution of Strategic Initiatives related to compliant supply, operationalizing quality and developing an engaged and capable workforce.
* This role will be based Europe but will support EU and/or AP areas.
* Amount of Travel Required: Ability to travel up to 25% of the time.
**What skills you will need:**
In order to excel in this role, you will more than likely have:
* At least 10 years pharmaceutical manufacturing experience (GMP) with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP Quality Systems and regulatory requirements.
* Aseptic manufacturing experience, experience with regulatory inspections and knowledge of multi-national regulatory agency cGMP expectations required.
* Communicates easily in English both verbally and in writing.
* Must have strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships.
* Experience with manufacturing operations and/or analytical expertise associated with biologics and/or vaccines.
**Preferred skills and experience:**
* Direct experience with managing external partners strongly preferred.
* Meet the requirements of a Qualified Person as per EU Directive 2001/83/EC and 2001/20/EC preferred.
* Familiarity with analytical assays for sterile vaccine/biologic drug substance and/or drug product preferred.
* Experience with qualification of manufacturing facilities/equipment (i.e. Process/Cleaning Validation, IQ/OQ/PQ) preferred.
* Quality Risk Management (QRM) Experience (e.g. Risk Lead, Facilitator) preferred.
**Employee Status:**
Regular
**Relocation:**
No relocation
**VISA Sponsorship:**
No
**Travel Requirements:**
25%
**Flexible Work Arrangements:**
Not Applicable
**Shift:**
Not Indicated
**Valid Driving License:**
No
**Hazardous Material(s):**
N/A
**Required Skills:**
Adaptability, Adaptability, Complaint Management, Decision Making, Deviation Management, GMP Compliance, Interpersonal Relationships, Legal Agreements, Pharmaceutical Manufacturing, Process Improvements, Quality Agreements, Quality Assurance (QA), Quality Control (QC), Quality Control Management, Quality Management Systems (QMS), Regulatory Compliance, Regulatory Compliance Audits, Regulatory Compliance Consulting, Regulatory Inspections, Regulatory Requirements, Risk Management, Strategic Thinking, Supplier Management, Technical Management, Technical Projects {+ 1 more}
**Preferred Skills:**
**Job Posting End Date:**
06/25/2025