Responsible Person Dir Quality Assurance (m/f/d) at Merck Sharp & Dohme Corp. /Netherlands

Werthenstein, Lucerne, Switzerland -

Full Time

Start Date

Immediate

Expiry Date

20 Jun, 26

Salary

0.0

Posted On

22 Mar, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Auditing, Change Management, Client Relationship Building, Creativity, Cross-Cultural Awareness, Diversity Programs, Leadership, Mentoring Staff, People Leadership, Pharmacovigilance, Policy Implementation, Process Improvements, Quality Assurance, Quality Systems Compliance, Regulatory Compliance, Risk Management

Industry

Pharmaceutical Manufacturing

Description

Job Description The Biologics drug substance manufacturing facility at Schachen is a premier, state-of-the-art facility that enables and advances our best work. The facility supports early clinical supply based on a seamless connection and collaboration between process development and clinical manufacturing. We have an amazing new opportunity for a Director level Site RP (Responsible Person) at our Schachen site, with responsibilities for low bioburden drug substance manufacturing as well as clinical supply packaging and distribution activities. The Site RP (Responsible Person) is a key member of the Quality Leadership Team, having responsibility to ensure that the site meets the expectations as laid out in the Swissmedic Technical Interpretation (I-SMI.TI.17). Bring energy, knowledge, innovation to carry out the following: Act as the Responsible Person in support of site batch release, in conjunction with RP Delegates and Deputies. Execute Batch Record reviews and certification/release RP input to Deviation / OOS investigations Support Batch Disposition QMS Topic and Community of Practice. Support Material Review / Disposition process. Oversee site internal audit program for system and walk-through audits for all site operations Perform for–cause audits, review/approval of CAPA responses (including root cause analysis), and CAPA verification/effectiveness checks Lead audits; mentor/coach site auditors in all areas of performance; host guest auditors from other company sites; participate in opportunities to audit other company sites Mentor other auditors in cutting edge compliance/regulation/auditing skills Review and approve Audit Reports, including observation ratings and overall audit outcome Lead change and process initiatives related to audits, inspections, and CAPA Management of Major Change Notifications to Health Authorities. Oversight and approval of Technical and Quality Agreements with 3rd parties. Perform routine risk communication for Site (Quality Council), Regional, and Divisional Management Providing quality oversight and approval of, deviations, change controls, complaints and other lifecycle deliverables Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities. Utilise this network to help resolve comments and issues that arise during audit and review Identify compliance gaps, make and facilitate implementing recommendations for continuous improvement Carries out all assignments to the standards of compliance, efficiency, innovation, accuracy and safety in accordance with Company and regulatory requirements Keeps abreast of cGMP requirements as described in applicable worldwide regulations Represents department on cross functional teams Ensure Permanent Inspection Readiness across all QMS Topics Independent development, documentation and maintenance of business process and solutions Expert knowledge in specialised areas of technical expertise Additional activities as assigned by the manager/supervisor Provide first line of issue resolution/escalation for the team What skills you will need: In order to excel in this role, you will more than likely have: Bachelor’s degree, or higher, in a Life Science discipline. 10 Years + Experience in Quality Role in Sterile/Low Bioburden Biological Drug Substance Pharmaceutical Manufacturing and/or Clinical Supply Packaging and Distribution Eligible as Responsible Person as per I-SMI.TI.17. Previously acted as a Responsible Person Strong Experience in Quality Related enterprise systems e.g. LIMS, SAP-Quality, MES, Veeva Q-Docs Experience in supporting regulatory inspections, specifically, Swissmedic Strongly developed cross-functional teamwork, collaboration, influencing and negotiation skills Demonstrated excellence of skill in communicating (oral and written) effectively with various individuals/ groups at all levels Strong project management skills and experience; ability to conduct well defined projects on complex topics +Schachen, Canton Lucerne Our Werthenstein BioPharma site in Schachen is where we conduct cutting-edge research, develop and analyze new biological agents and supply clinical trial products for global clinical studies. The site is also home to one of our global forensic laboratories where we carefully monitor our products through the supply chain to ensure security and safety for our patients. Required Skills: Auditing, Change Management, Client Relationship Building, Creativity, Cross-Cultural Awareness, Diversity Programs, Leadership, Mentoring Staff, People Leadership, Pharmacovigilance, Policy Implementation, Process Improvements, Quality Assurance (QA), Quality Assurance Systems, Quality Investigations, Quality Systems Compliance, Regulatory Compliance, Risk Management Preferred Skills: 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: 10% Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: *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:R389140

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Responsibilities

The Director level Site RP is responsible for ensuring the Schachen facility meets Swissmedic expectations, acting as the Responsible Person for site batch release in conjunction with delegates. This role involves overseeing internal audits, leading change initiatives related to audits and CAPA, and managing technical/quality agreements with third parties.