Job Description
The Associate Director, Quality Systems and Compliance is responsible for leading the Quality Systems group and oversee the Quality Assurance Systems to be compliant with GMP regulations (which includes Management of Change Controls, Deviations, Complaints, Records, Suppliers, Audits, Quality Risk Management, Data Integrity , Quarantine & Stock Recovery plus Third Party Provider Oversight). Key requirements of the role also include ensuring the continued evolution of a quality culture across stakeholder groups via the development and implementation of effective and efficient compliance and business processes with a strong operational focus aligned with business drivers.
Oversight and leadership of the compliance to the Quality Manual, as well as expertise in Compliance and Quality Systems to provide guidance on Quality Manual requirements. Driving permanent inspection readiness at the site as well as supporting Health Authority Inspections.
Ensuring site Compliance through a range of programs including training, audits, self inspections, trend reports, metrics etc.
Supporting the development and execution of quality strategies, improvement initiatives in line with business drivers and objectives to ensure and enhance the robustness of our compliance posture whilst streamlining processes and procedures.
Provision of in-depth technical / quality expertise re; development of identification of trends and/or potential compliance gaps and proactively leading the resolution of long-standing or significant issues affecting quality and efficiency.
Coaching, mentoring and developing team members supporting their personal development.
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.
Primary skills include but are not limited to:
Bachelor Degree in Engineering, Biology, Chemistry or related field.
A minimum of 5+ years of relevant experience working within the pharmaceutical industry or advanced Degree with 3+ years relevant experience, ideally related to Compliance or Quality Systems.
Experience interacting with regulatory officials
Strong compliance knowledge and understanding of regulatory agency regulations and requirements and interpretation and application re; GMPs to a R&D environment
Demonstrated knowledge of continuous improvement methodologies; ability to direct complex cross-functional initiatives
Demonstrated leadership, incl. strategy development and deployment experience with tangible delivered benefits in a development environment
Demonstrated experience in quality risk management in the pharmaceutical industry
Strongly developed cross-functional teamwork, collaboration, influencing and negotiation skills
Experienced and strong people manager with proven track record of developing talent
Demonstrated excellence of skill in communicating (oral and written) effectively with diverse individuals/ groups at all levels
Strong project management skills and experience; ability to conduct well defined projects on complex topics
Our Manufacturing & Supply Division is committed to be the most trusted supplier of biopharmaceuticals 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
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 (Weystrasse, Citybay, Schachen and Kriens). A fifth location has been recently 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. The new location has a target date of 2021 for operational readiness.
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.
At our Werthenstein BioPharma site in Schachen we research, develop and analyze new biological agents and new products, deliver clinical trial products for global clinical studies and operate one of our global forensic laboratories.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
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.
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:
RegularRelocation:
No relocationVISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
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Hazardous Material(s):
Number of Openings:
1Requisition ID:R83529