External Site Quality Lead - Biologics (m/f/d)
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External Site Quality Lead - Biologics (m/f/d)
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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.
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.
The Company
Our company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Tribschenstrasse, Citybay, Schachen and Kriens). A fifth location has been established in Zurich, aimed at accelerating the development and commercialization of many of our company’s medicines and vaccines, which supports our mission to save and improve lives around the world.
We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s commitment to our employees and the community around us.
Our Tribschenstrasse office, located in the city of Luzern has a rich diversity of employees at this location including Global Supply Chain Management, Regional External Manufacturing and one of our European Finance Hubs. The site also serves as our regional and local headquarters for our company’s Animal Health Division in Switzerland.
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
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
* A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID R352600
Seniority level
* Seniority level
Not Applicable
Employment type
* Employment type
Full-time
Job function
* Job function
Information Technology
* Industries
Biotechnology Research, Pharmaceutical Manufacturing, and Veterinary Services
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