at Merck in Millsboro, Delaware, United States
Job Description
Job Description
Associate Director, Quality Assurance – Millsboro, Delaware
Purpose of Role:
The Associate Director, Quality Assurance at the Millsboro, Delaware site reports to the Site Quality Head and will lead the activities of the Quality Assurance team, as well as influence and execute quality initiatives at the site. This requires partnership and collaboration with all site functions (Operations, EHS, Maintenance/Engineering, BTS/ATS and Regulatory Affairs) to ensure site quality systems, processes and projects fulfill the needs of our stakeholders and meet/exceed regulatory. Collaborates with site leadership on quality standards and release criteria to ensure that all products are pure, safe, potent, and efficacious. Facilitates an environment of continuous improvement.
Activities within Role include:
+ Manages, coaches, and develops Quality Assurance personnel at the Millsboro, Delaware site
+ Takes action to ensure appropriate quality systems are in place at all stages of manufacturing and testing.
+ Reports quality results and metrics to the Site Quality Head, and site leadership.
+ Ensures escalation of quality related events and facilitates timely resolution/closure.
+ Manages compliance related regulatory submissions.
+ Ensures that all products released to the market are manufactured within regulatory and internal standards.
+ Assists departmental and site personnel in resolution of any significant deviation investigations, customer complaint investigations, and issuance of regulatory notifications.
+ Serves as a liaison with regulatory agencies during inspections. Ensures that all regulatory inspection observations are addressed in a complete and effective manner.
+ Ensures Quality Organization is compliant to safety policies and all operations are carried out in a safe manner.
+ Responsible for driving a culture of Continuous Improvement
+ Develop an effective team by understanding their abilities, unique contribution and broadening their skills to be agile and prepared for any future business requirements.
The successful candidate will have the following skills and experience:
+ 10+ years industry experience in a biologics setting
+ Proven leadership experience in either Quality or Manufacturing environment
+ Working knowledge of regulatory requirements in accordance with both USDA and GMP regulations for veterinary biologicals.
+ Experienced in leading domestic and international health authority inspections.
+ Knowledge of veterinary biologicals production and testing platforms.
+ Principled communication skills; able to communicate company and site strategies to direct reports and site employees.
+ Proficiency in computer systems and applications including but not limited to: Microsoft Project, Microsoft Office (Word, Excel and Outlook)
Education Requirement:
+ Associates Degree
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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