Assoc. Dir, External Quality
hace 2 semanas
Job DescriptionOur 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 External Quality who is accountable for activities at the External Entity (EE) site associated with the manufacturing of Company products which includes quality oversight over manufacturing, testing, packaging, storage, and distribution of the products manufactured at an EE and to assure they have been produced or tested following approved processes/methods in conformance to all applicable regulatory requirements, regulatory filings and company policies.The incumbent is also a subject matter expert for both EQA and manufacturing division in specific Quality Systems, technology platforms, regulatory expectations and/or external entity management. The incumbent may also serve as the representative of our company in outside forums on their area of expertise, driving complex cross-functional initiatives to develop/optimize Quality/business processes applying risk-based approaches and driving continuous improvement activities at the external entity.Primary activities include, but are not limited to:Accountable for all aspects of end-to-end External Entity performance, and serve as the primary contact for the relationship, apply risk-based approaches and drive continuous improvement activities.Provide leadership and direction to help execute a risk-based system for calibrated quality oversight based on the product type as well as the capabilities and quality performance of an external manufacturer.Establishes clear expectations, measures and periodic monitoring of operational and quality performance associated with External Manufacturing. Provides leadership for oversight of quality due diligence assessments for pre-approval considerations of new external providers.Provides leadership and strategy to ensure the establishment and maintenance of Quality Agreements.Direct and manage major External Manufacturing Quality investigations, ensure that Significant Investigations and Fact Findings are organized appropriately and co-ordinate any recalls as appropriate.Participate as a member of an EQA Platform / Regional Leadership Team and other committees as appropriate.Exhibits our company Leadership Behaviors and provides a leadership example for the team.Works strategically and in collaboration with other functions to continuously improve our company's effectiveness and efficiency in quality management and quality systems supporting the external network.Moderate level of contractual and financial awareness.Prior people management experience preferred.Ability to travel 25%, occasionally on short notice.SkillsREQUIRED: Education and Experience:Education: Minimum four year degree in Science, Engineering or other relevant technical discipline (e.g. BS/MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred).Minimum of 12 years relevant experience in the pharmaceutical industry and/or biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.Experience in Sterile Manufacturing/PSIM required.Strong experience required in Deviation Management, Change Control and support of filings.Must have strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships.Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills.Communicates in English, both verbally and in writing.The role needs to be based in EU (ideally in Switzerland, Ireland, Italy or Spain) – No relocation provided.THE COMPANYOur 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 HERECurrent Contingent Workers apply HERESearch Firm Representatives Please Read CarefullyMerck & 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: RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements: HybridShift:Valid Driving License:Hazardous Material(s):Job Posting End Date: 12/24/2024*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.
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