Job Information
Merck Associate Director Quality Systems in Durham, North Carolina
Job Description
The Associate Director of Quality Systems provides leadership, focus, and governance to the Hilleman site in the following Quality Systems: Deviation Management, Complaints, Corrective Action/Preventive Action Management, Annual Product Review Authoring, Quality Risk Management, and Quality Council. The incumbent leads a team responsible for instituting consistent practices within the facility across these disciplines. The successful candidate will build and improve these site-wide management programs by defining requirements established via in-depth review of existing systems and aligned with strategic direction defined by the global business model and regulatory agencies. The role will require working with both global and local teams. As a Sub-System Owner of these systems for the site, the incumbent will also be responsible for the measurement of metrics and presenting the system during audits and inspections.
GENERAL PROFILE:
Effectively manages and develops employees.
Contributes to the overall performance and results of the site.
Adapts departmental plans and priorities to address resource and operational challenges.
Administers decisions guided by policies, procedures, and business plans and seeking guidance from leadership; when appropriate.
Provides technical guidance to employees and colleagues.
Anticipates and interprets client and/or customer needs to identify solutions.
BUSINESS EXPERTISE:
Applies management skills to align staff activities with department objectives.
Understands and applies regulatory/compliance requirements.
FUNCTIONAL EXPERTISE:
Specific to the following Quality Systems (Deviation Management, Complaints, Corrective Action/Preventive Action Management, Annual Product Review Authoring, Quality Risk Management, and Quality Council), the Associate Director will be responsible for comprehensive management of all activities required to successfully support the site to include the following:
Provides management and leadership for the above-listed Quality Systems to ensure compliance with all global and regulatory standards.
Develops and report to senior leadership data analysis and metrics to ensure systems’ compliance and performance.
Serves as a sub-system owner for the Durham site for the above-listed Quality Systems.
Represents Durham in above site initiatives associated with the above-listed Quality Systems and other related initiatives.
Supports SOP development and/or approval as needed.
Ensures support of regulatory inspections and audits for the above-listed Quality Systems.
PROBLEM SOLVING:
Identifies and resolves technical and operational problems.
Collaborates with peers to resolve problems that cross into interrelated units.
IMPACT:
Influence
Explains difficult concepts and persuades others to adopt point of view.
Communicates information, asks questions and checks for understanding.
Accountability
Accountable for the performance of work group
Decision Making
Makes decisions – guided by policies and procedures – that impact the unit’s ability to meet performance objectives.
Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with interrelated processes.
STRATEGIC PLANNING:
- Adapts and implements departmental plans and priorities based on division scorecard to address local business, service and operational challenges.
RESOURCE MANAGEMENT:
- Forecasts resource needs; manages allocated budget.
Required
Bachelor’s degree in engineering, Science, or related areas of study.
Minimum 8 years’ experience in the pharmaceutical industry with significant experience in biologics, vaccines, and/or bio-pharmaceuticals compliance.
At least 5 years of supervisory/management experience.
Prior experience working in pharmaceutical/vaccine manufacturing facility.
Demonstrated knowledge of GMPs, compliance issues, inspectional trends, industry quality assurance practices and systems, and personnel management skills.
Proven application of effective supervision principles.
Works independently with all levels of the organization and has demonstrated the following skills: Rapid / Disciplined decisions, Acts with courage and candor.
Drives results, escalation of issues / concerns to management, as appropriate.
Ability to prioritize, align and simplify tasks.
Ability to interpret complex business and/or technical documents, write comprehensive reports and detailed business correspondence and the ability to present to groups across the organization as needed.
Prior knowledge and/or use of cGMPs, technical writing, data management collection, and analysis.
Demonstrates an innovative mindset.
Demonstrates cross cultural agility and resourcefulness.
Proven expertise with:
Technical Writing and Presentations
Lean 6 Sigma methodologies.
Preferred
- Advanced degree
WORKING RELATIONSHIPS:
Reports to the Director of Quality
Frequent interactions with employees from other departments
Interacts with representatives from regulatory agencies.
Interacts with external suppliers.
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.
VETJOBS
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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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
EEOC GINA Supplement
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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”.
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:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
09/26/2024
*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: 09/26/2024
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: R313244