Job Information
Merck Senior Specialist, Medical Device & Combination Product (MDCP) Operations Lead in Wilson, North Carolina
Job Description
Job Description
This Senior Specialist, MDCP Operations Lead position will serve as the primary medical device and combination product (MDCP) point of contact for the Wilson, NC site Operations team. Responsibilities for this position will include providing ownership for various MDCP related programs at the site including launch of new products. This position will be accountable for building MDCP related capabilities at the site and will own efforts to establish and maintain ISO 13485 certification. This position will also act as liaison between the site and global MDCP teams (Technical, Quality, etc.), providing hands-on shop floor perspective and advocating for processes that are both compliant and pragmatic.
Responsibilities
The Senior Specialist, MDCP Operations Lead position is responsible for providing strategic leadership to the site’s MDCP program. Primary responsibilities include ensuring that high standards for MDCP compliance are maintained at the site and that key projects related to these products are executed effectively. Additional activities, responsibilities, and competencies include but are not limited to the following:
Compliance:
Act as site subject matter expert for MDCP related compliance. Ensure site operates within established MDCP policies, procedures, ISO standards, and applicable Health Authority regulations (21 CFR Part 4, QMSR, and EU MDR).
Establish and maintain quality management systems compliant with ISO 13485 standards and relevant MDCP regulations.
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.
Delivery:
Apply device risk management and design control principles to develop and apply value-add solutions to customer needs in medical devices and combination products.
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.
Collaborate with cross-functional teams to implement corrective and preventive actions based on assessment findings.
Resolve or escalate MDCP related concerns with the potential to impact product launches or supply.
Cost
Ensure that activities are carried out in accordance with departmental budget.
Recognize and implement opportunities related to MDCPs to realize efficiency and financial savings.
People and Team:
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.
Build effective relationships with other functional areas as well as stakeholders across the internal network.
Strategic Support and Continuous Improvement:
Provide MDCP related leadership to medical device and combination product launches at the site.
Partner with external stakeholders to develop, commercialize, and sustain medical devices and combination products assembled or packaged at the site.
Support the company's ISO 13485 certification efforts.
Execute continuous improvement initiatives to enhance the overall MDCP culture within the organization.
Establish and maintain effective MDCP-related processes and systems.
Education Minimum Requirement
- B.A./ B.S. degree (preferably in Science or Engineering related field)
Required Experience and Skills
Minimum 5 years of experience with focus on MDCP product development or manufacturing operations.
Experience in design controls, device risk management, medical device, combination products, prefilled syringes, autoinjectors, process validation, automation and/or related concepts.
Thorough understanding of ISO 13485, 21 CFR Part 4, QMSR, and EU MDR.
Strong communication skills: ability to effectively communicate with cross-functional teams, auditors, and regulatory authorities.
Experience supporting regulatory inspections (FDA, EMA, etc.) and/or Notified Body audits.
Preferred Experience and Skills:
Experience with technology transfer of medical device and combination products from development to commercialization.
Experience in commercialization of high-volume medical device or combination products.
Experience with injection molding and working with medical device suppliers.
Experience leading Quality Management System gap assessments against regulations and standards.
Strong influencing skills: ability to provide leadership to initiatives, drive change, influence stakeholders.
Project management skills: ability to prioritize tasks, manage timelines, and meet deadlines.
Problem-solving skills: ability to identify gaps, analyze complex issues, and develop effective solutions.
Adaptability: able to work in a dynamic and fast-paced environment, adapting to changing priorities and requirements.
Strong written and verbal communication skills including technical writing experience (investigations, change requests, standard operating procedures, protocols, etc.).
Reporting Relationships:
Solid line report to: Director, Operations
Dotted line report to: N/A
Position(s) reporting to this position: N/A
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
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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:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
10/5/2024
*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: 10/05/2024
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: R314234