Director, External Quality - Remote

MSD • Durham, NC

1d • Remote

About The Position

Leading a team of quality professionals ensuring compliance and quality oversight across external manufacturing of products and devices. In this role you will be subject matter expert in EQA and manufacturing quality systems, technology platforms, regulatory expectations, and external manufacturing management, with the opportunity to represent the company in external forums. Leads complex cross-functional initiatives to optimize quality and business processes driving continuous improvement. Bring energy, knowledge, innovation to carry out the following: Lead a team of quality professionals accountable for activities at the External Entity (EE) site associated with the manufacturing of Company Products and Devices. Provide quality oversight over molding, manufacturing, assembly, testing, packaging, storage, and distribution of products manufactured at an EE. Ensure products are produced or tested following approved processes/methods in conformance to all applicable regulatory requirements, regulatory filings, and company policies. Act as a subject matter expert for both EQA and our manufacturing division in specific Quality Systems, technology platforms, regulatory expectations, and/or external entity management. Represent our company in outside forums on areas of expertise, driving complex cross-functional initiatives to develop/optimize Quality/business processes. Manage and lead a small team of Quality Assurance professionals, holding regular 1-on-1 meetings and Employee Development Plan discussions. Collaborate with other functions to continuously improve our company's effectiveness and efficiency in quality management and quality systems supporting the external network. Oversee performance management processes including objectives setting, approval, revision, year-end accomplishment evaluation, and performance discussions with direct reports.

Requirements

• Minimum four-year degree in Science, Engineering, or other relevant technical discipline (e.g., BS/MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent).
• Minimum of 12 years relevant experience in the Pharmaceutical and/or Medical Device industry with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control including solid knowledge of global GMP and MDCP regulatory requirements.
• Good knowledge and experience with MDCPs.
• Strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships.
• Ability to work across boundaries; demonstrated interpersonal, relationship building, and leadership skills.
• Proficiency in English, both verbally and in writing.
• Previous experience participating in regulatory inspections.
• Familiarity with domestic and foreign regulations and compendia governing plant operations.

Nice To Haves

• 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.
• As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.
• As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
• For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement
• We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds.
• The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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
• San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
• Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
• 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 place, introductions are position specific. Please, no phone calls or emails.

Responsibilities

• Lead a team of quality professionals accountable for activities at the External Entity (EE) site associated with the manufacturing of Company Products and Devices.
• Provide quality oversight over molding, manufacturing, assembly, testing, packaging, storage, and distribution of products manufactured at an EE.
• Ensure products are produced or tested following approved processes/methods in conformance to all applicable regulatory requirements, regulatory filings, and company policies.
• Act as a subject matter expert for both EQA and our manufacturing division in specific Quality Systems, technology platforms, regulatory expectations, and/or external entity management.
• Represent our company in outside forums on areas of expertise, driving complex cross-functional initiatives to develop/optimize Quality/business processes.
• Manage and lead a small team of Quality Assurance professionals, holding regular 1-on-1 meetings and Employee Development Plan discussions.
• Collaborate with other functions to continuously improve our company's effectiveness and efficiency in quality management and quality systems supporting the external network.
• Oversee performance management processes including objectives setting, approval, revision, year-end accomplishment evaluation, and performance discussions with direct reports.

Benefits

• We are committed to flexible working where possible, and is why our Company has introduced a new hybrid working model for office-based colleagues around the world. Please feel free to speak to us about what flexibility means to you during your application.

What This Job Offers

• Job Type: Full-time
• Career Level: Director