Executive Director, Quality

Job Description

The Executive Director, Quality position serves as the leader for the Quality Operations organization at one of our sites. This position is responsible for ensuring all aspects of quality and GMP compliance are maintained at the site covering every aspect of plant, lab and stability operations related to the quality of products produced and tested. This position is also a member of the Site Leadership Team.

The Executive Director, Quality position is responsible for assuring that all products or devices packaged, manufactured, or assembled at the site have been produced in compliance to approved processes in conformance to all applicable regulatory requirements and company policies. This also includes global stability studies for our company's product. The position is responsible for providing day to day tactical and strategic direction to the Quality Operations team, ensuring that business and compliance objectives are met within budgetary constraints, and that a high standard for compliance is maintained within the site. The position will also be expected to promote behaviors of continuous improvement (aligned with our company's principles) and ensure that the Quality Operations team maintains a positive and inclusive culture.

Job Function:

The Executive Director, Quality position is responsible for providing day to day tactical and strategic direction to the site Quality Operations team of approximately 100 employees. Primary responsibilities include ensuring that a high standard for compliance is maintained at the site, business and compliance objectives are met, and that the Quality team works within its financial budget.

Additional activities, responsibilities, and competencies include but are not limited to the following:

Compliance:

• Most responsible Quality person for the site with responsibility for directing the site cGMP program.
• Assures that Quality team and site operates within established policies, procedures, and applicable Health Authority regulations. Responsibilities to include analytical testing, batch release, approval for deviations, project qualifications support, complaint management, supplier management, stability studies and internal auditing.
• Acts as key regulatory compliance liaison interfacing with regulatory agencies for reporting and inspections.
• Possesses experience applying Quality Management Systems and appropriate knowledge of relevant regulations and the pharmaceutical industry for a wide variety of site disciplines and topics.
• Utilizes a high degree of independent judgment and decision-making to manage GMP related concerns including deviation and product quality complaints management. Escalate to our company's leadership or regulatory agencies where appropriate.
• Ensures that Quality team executes its duties in compliance with Safety, Environmental, and Labor regulations.

Delivery:

• Ensures that Quality team effectively supports production, packaging, and other site operations to assure compliant and reliable customer supply.
• Maintains laboratory operations to provide Quality Control services to the site and broader network including incoming analysis of materials, identity testing, release testing, environmental monitoring, and stability testing of APIs and finished goods.
• Resolve and escalate issues with the potential to impact supply within daily, weekly, and monthly management processes.

People and Team:

• Provides leadership to the Quality organization which includes approximately 100 team members with responsibility for Quality Assurance / IPT support (Integrated Process Team), Quality Control, Quality Management Systems, and Internal Auditing.
• Defines and staffs positions as appropriate to fulfil the responsibilities of Quality Operations at the site.
• Directly manages the Quality Leadership team (approximately 6 leaders). Ensure that a culture of inclusion and consistency is maintained within the Quality team with a focus on coaching, development, equitable application of policy, and performance management where appropriate.
• Serves as a member of the site leadership team, supports, and builds effective relationships with other functional areas as well as stakeholders across our company's network.

Cost:

• Responsible for developing and ensuring adherence to the Quality team operating budget of approximately $17MM.
• Proposes and manages capital projects associated with laboratory operations as required to meet current and future business needs.

Strategic Support and Continuous Improvement:

• Helps develop strategy for the Quality team and site. Executes against tactical plans to meet those strategic goals.
• Provides compliance, validation, analytical, and change control support to the site to facilitate and qualify new product introductions.
• Embeds a culture of continuous improvement and MPS into the Quality team focused on compliance, standard work, making problems visible, minimizing waste, reducing process variability, and problem solving.

Minimum Education Requirement and Experience:

• Bachelor of Science (BS) degree in chemistry, pharmacy, biology, engineering, or a related science field with fifteen (15) years of pharmaceutical industry work experience; OR
• Master of Science (MS) degree in chemistry, pharmacy, biology, engineering, or a related science field with twelve (12) years of pharmaceutical industry work experience; OR
• PhD in chemistry, pharmacy, biology, engineering, or a related science field with ten (10) years of pharmaceutical industry work experience

Required Experience and Skills:

• Minimum 6 years of managerial experience.
• Understanding and ability to appropriately apply cGMPs, GLPs, and regulatory requirements.
• Demonstrated strong leadership and interpersonal skills with ability to coach, influence, and support teams within a diverse, equitable, and inclusive culture.
• Demonstrated ability to motivate teams to achieve stretch goals

Preferred Experience and Skills:

• Experience in more than one functional area, including Quality management.
• Strong written and verbal communication skills including technical writing experience (investigations, change requests, standard operating procedures, protocols, etc.)
• Experience in Continuous Improvement, Lean Manufacturing, Problem Solving, and/or Right First Time methodologies
• Experience supporting regulatory inspections including FDA

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".

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*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:05/29/2024

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:R296783