Job Detail

JOB DESCRIPTION

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Based in Schachen, Switzerland, we are looking for an Associate Director Quality Assuranceto support our Integrated Project Team (IPT) for Biologics at our Werthenstein BioPharma site. (Full-time, indefinite).

In this role the Associate Director Quality Assurance will focus on the quality support for the manufacturing and testing of Biologics, and clinical release of biological Drug Substances and sterile Drug Products at our site in Schachen. The role includes responsibilities for compliant evaluation and implementation of cutting-edge technologies, development of procedures and best practices supporting the global organization and the Schachen site.

The Associate Director Quality Assurance will interact with global and local stakeholders and exercise leadership in monitoring and maintaining compliance with worldwide regulatory requirements, current Good Manufacturing Practices (cGMPs), Quality Manual, and pertinent legal and / or business contract requirements. Key responsibilities may include upskilling employees for Quality, Compliance and Regulatory improvements, leading deviation investigations, change requests, and interfacing with other Company sites. The Associate Director Quality Assurance will assist the IPT Biologics Associate Director in interfacing with local and global groups, including other Quality groups.

THE PRIMARY ACTIVITIES INCLUDE BUT ARE NOT LIMITED TO:

• Act as Quality leader in global and local teams for the evaluation and implementation of new technologies.


• Take responsibility for the timely release of clinical Biologics (DS, sterile DP, and secondary packaged clinical supplies).


• Manufacturing Batch Record Review of Biologics (DS, sterile DP, and secondary packaged clinical supplies).


• Closely collaborate with the appropriate business/operations areas to ensure that effective and robust Quality systems and processes are in place.


• Serve as a point of contact for issue resolution and liaise with other functions locally and globally.


• Support investigations and changes in related stakeholder areas.


• Support equipment qualifications and computer system validations in related stakeholder areas.


• Conduct Walkthrough Audits and Internal Audits / Supports the Quality on the Floor program.


• Support analytical method validations (incl. microbiological testing) for in-house and outsourced analytical testing.


• Track and monitor local operational and quality performance. Escalate issues to the IPT Biologics Quality Associate Director as appropriate.

QUALIFICATIONS:

Technical Skills:

• Bachelor’s or Master’s Degree in life sciences required, ideally in Biotechnology, Microbiology or Chemistry studies. 


• Minimum of 10 years’ experience in Quality in one of the following areas: Technical Operations, Quality control, Engineering in Quality related to equipment qualification or Quality Compliance functions.


• Minimum of 7-years’ experience in GMP environment within the pharmaceutical business.


• Experience with Drug Substance batches in Biologics manufacturing and/or Steriles.


• Demonstrated Quality experience in the areas of Sterile Biologics manufacturing. Experience in continuous manufacturing is an asset.


• Strong understanding of regulatory agency regulations and requirements (Swiss, EU and FDA).


• Proficiency in interpreting and applying cGMPs to R&D environment, including data management, collection, and Analysis. Excellent experience with Good Documentation Practices.


• Demonstrated problem-solving and Project Management skills, preferably with Six Sigma Tools.


• Experience with Internal and External Audits.


• English and German language – Proficiency at a business level is necessary.

Personal competences:

• Very strong project management skills, as well as high sense of responsibility. Ability to independently manage multiple priorities and projects. Very strong Time-management skills.


• Ability to lead matrix teams, recognize improvement opportunities, develop appropriate solutions and follow through on implementation.


• Excellent interpersonal skills. Appreciative and respectful of cultural diversity and norms in a team.


• Demonstrated ability to effectively collaborate and influence internal and external stakeholders. Demonstrated successful opinion leaders’ management.


• Ability to work independently within Quality and drive results.


• Ability to work within a global matrix organization and leverage expertise from other functions and Departments.

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time

THE COMPANY…

Surrounded by the Swiss Alps in the heart of Switzerland, we have four sites in and around the Lucerne region. Switzerland serves as our regional headquarters and 1,000 employees from more than 50 nations work collaboratively in national and international positions. Our people work in a diverse range of functions including Sales, Marketing, Policy, R&D, Manufacturing, Quality Assurance, Clinical Research and Support Functions. Global Supply Chain Management is located in Switzerland with logistics and transportation being coordinated across more than 140 markets. At our Werthenstein BioPharma site in Schachen we research, develop and analyse new biological agents and new products, deliver clinical trial products for global clinical studies and operate one of our three global forensic laboratories.

We are proud to take an active role engaging with the local community, supporting the “Trendtage Gesundheit Luzern” health congress and sponsoring the “Swiss City Marathon Lucerne”. We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing our commitment to our employees and the community around us.

WHO WE ARE …
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
 

WHAT WE LOOK FOR …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
 

INVENT.
IMPACT.
INSPIRE.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

No Travel Required

Flexible Work Arrangements:

Work Week

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R15241