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Site Quality Head

3 months ago

Worthington, Minnesota, United States Merck Full time

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Position Description:

  • The Site Quality Head directs the Quality and Compliance activities at the Site, provides support and expertise in these areas, and manages the Quality Teams in including Quality Control & Quality Assurance at the Worthington, Minnesota site.
  • The selected candidate will collaborate with the Regulatory Affairs, Manufacturing, Environmental Health, and Safety (EHS), R&D, Biotechnology Solutions (BTS) teams to ensure site Quality systems, processes and projects are in place that meet the agency requirements and company standards.
  • Collaborate with the site leadership on implementing and maintaining our Company's quality standards and ensures testing and release of Quality products in a compliant environment to ensure the safety, efficacy, and potency specifications of the products as well as their alignment with the outlines/special outlines of production.
  • Manage team members to include coaching on quality principles, inclusive behaviors, and best practices.
  • Interact with other Company sites and closely works with other US sites part of the USDA establishment license.

Key Functions:

  • Guides the team for the execution of product testing, release and maintaining licensure as per the USDA-CVB Virus-Serum-Toxin Act.
  • Oversees and assists in the USDA submissions, escalation, and notifications.
  • Leads the QC and QA teams in implementing the best practices, Quality principles and our Company's leadership behaviors.
  • Actively assesses the performances of her/his teams, develops, and coaches' talents and ensures succession planning within the organization through mentoring and development programs.
  • Partners with the site leads in defining and implementing site's annual strategy in alignment with the GAHM strategy.
  • Promotes, integrates, and monitors the implementation and maintenance of Environmental Health and Safety (EHS) management systems in laboratory and other parts of quality department, in working with the site leadership team to ensure enhancement and maintenance of the site safety.
  • Drives the culture of continuous improvement and target zero within a Quality Management Systems framework towards a compliant, effective, and efficient Quality organization.
  • Oversees schedules for testing and other activities in accordance with customers' requirements.
  • Manages site events and deviations, assesses the risks, and provides recommendations on the actions and steps forwards as relates to the mitigation of the risks.
  • Escalates the deviations and other quality and compliance matters to the US Regional Lead and other Quality leadership as required per the management notification process.
  • Ensures that the Quality Organization provides timely and effective supports for the product supply chain for the on-time delivery of Quality and compliant products to customers in time.
  • Partners with other Site Quality Heads, Quality and Safety SMEs, Technical Support, R&D and the Regulatory Affairs to ensure effective collaboration and communication and obtain these resources for supporting the Sites' activities as necessary.
  • Collaborates with the operations in MPS activities, considering people development on MPS skill sets and methodologies. Identifying resource needs and/or technical knowledge gaps to acquire institutionalization status in MPS tools (tier, kata...)

Minimum Education Requirements and Experience:

  • Bachelor's degree (BS) in a related science, biology, or animal science area with seven (7) years of industry experience in a biologics setting with demonstrated people management experience; OR
  • Master's degree (MS) in a related science, biology, or animal science area with five (5) years of industry experience in a biologics setting with demonstrated people management experience.

Required Experience and Skills:

  • This is a site-based role, and the individual is required to work from her/his office at Worthington. Must reside near or be willing to relocate to Worthington, Minnesota.
  • Working knowledge of regulatory requirements in accordance with the USDA regulations.
  • Proven people development and coaching skills.
  • Excellent communication skills; ability to communicate company and site strategies to direct reports and site employees.
  • Working knowledge of laboratory, Quality Control and Quality Assurance in a biologic setting.
  • Proficiency in computer systems and applications including but not limited to: Microsoft Project, Microsoft Office (Word, Excel, and Outlook).
  • Must be able to lead in a team based empowered culture.
  • Ability to work independently and effectively with peers; display strong interpersonal and organizational skills.
  • Prior Site Quality experience within Human Health or Animal Health strongly preferred.

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high quality, reliable supply to customers and patients on time, every time.

#EBRG

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

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

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

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:

Domestic/International

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

06/12/2024

*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:06/12/2024

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:R277177