Operations Lead - Medical Device and Combination Products

Job Description

Are you passionate about driving innovation and ensuring compliance in the Medical Device and Combination Product (MDCP) space? We are seeking a Senior Specialist to join our Operations team as the MDCP Operations Lead. In this role, you will serve as the primary point of contact for all MDCP-related matters, taking ownership of various programs including the ISO 13485 certification of our site.

Welcome to our team

From Haarlem, we distribute 2,500 different pharmaceutical and vaccine products to over 140 countries. Haarlem is known as the flexible packaging location in Europe, with short lead times and small batch sizes. We have 3 production/packaging departments in Haarlem where tablets, capsules, sachets, bottles, ampoules, and syringes are packed in various configurations, making our packaging lines diverse in terms of technology and processes. Our innovative company is constantly developing new medications, many of which are MDCP products that are launched from Haarlem. The 3 departments operate largely independently, with their own staff and technical service. As the MDCP Operations Lead, you will work in the Specialties department and report directly to the Director of Operations.

The position

As our new MDCP Operations Lead, you'll be our MDCP go-to expert within our site Operations team. You'll take charge of various MDCP programs, including the exciting launch of new products, and ensure that our site maintains its ISO 13485 certification. Your role will be pivotal in building our MDCP capabilities, and you'll act as the essential bridge between our site and the global MDCP teams (Technical, Quality, etc.). With your hands-on, practical approach, you'll advocate for processes that are not only compliant but also practical, directly from the shop floor.

Your responsibilities

• Act as site subject matter expert for MDCP related compliance.  Ensure the site operates within established MDCP policies, procedures, ISO standards, and applicable Health Authority regulations (21 CFR Part 4, QMSR, and EU MDR);

• Utilize device risk management tools to build device or combination product risk management programs from development through life cycle management;

• Prepare the site for MDCP related audits by Notified Bodies and regulatory agencies, including hosting audits and addressing audit findings;

• Provide support to device assembly, packaging, and other site operations to rapidly resolve concerns and assure compliant and reliable customer supply;

• Provide Business review and approval of MDCP related GMP documentation;

• Provide guidance and training to employees on requirements and best practices related to MDCP standards and regulations;

• Develop and execute against strategy to build MDCP capabilities at site;

• Execute continuous improvement initiatives to enhance the overall MDCP culture within the organization.

We are looking for

• HBO/Bachelors preferably in Science or Engineering

• A minimum of 5 years of experience in the pharmaceutical industry, specifically in MDCP product development or manufacturing operations, is required. Alternatively, candidates should have at least 5 years of experience in Medical Device operations, including hands-on production floor experience.

• Skilled in business communication in both Dutch and English

What we offer

We welcome you to a truly global, dynamic, and challenging environment with great opportunities for personal development. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.

• Competitive salary and a 3% year-end bonus;

• 35,5 days of leave;

• Attractive collective health care insurance package with considerable reduction rates;

• Solid Pension Plan;

• Incentive Plan;

• Travel allowance for commuting;

• Free in-house sport facilities

• Numerous training, coaching and e-learning modules for long term job opportunities and development.

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

10/16/2024

*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.

Job Posting End Date: 10/16/2024

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.

Requisition ID: R314569