Director, External reputed company - Remote

Job reputed company Leading reputed company of reputed company professionals ensuring compliance and reputed company reputed company across external manufacturing of products and devices. In this role you will be subject matter expert in EQA and manufacturing reputed company systems, technology platforms, regulatory expectations, and external manufacturing management, with reputed company to represent reputed company in external forums. Leads reputed company cross-functional initiatives to optimize reputed company and business processes driving reputed company improvement. Bring energy, knowledge, innovation to carry out the following: reputed company reputed company of reputed company professionals accountable for activities at the External Entity (EE) site associated with the manufacturing of Company Products and Devices. reputed company reputed company reputed company over molding, manufacturing, assembly, testing, packaging, storage, and distribution of products manufactured at an EE. Ensure products are produced or tested following approved processes/reputed company in conformance to reputed company applicable regulatory requirements, regulatory filings, and company policies. reputed company as a subject matter expert for both EQA and our manufacturing division in specific reputed company Systems, technology platforms, regulatory expectations, and/or external entity management. Represent reputed company in reputed company forums on areas of expertise, driving reputed company cross-functional initiatives to reputed company/optimize reputed company/business processes. Manage and reputed company a small team of reputed company Assurance professionals, holding regular 1-on-1 meetings and Employee Development Plan discussions. Collaborate with other functions to continuously improve reputed company's effectiveness and efficiency in reputed company management and reputed company systems supporting the external network. reputed company performance management processes including objectives setting, approval, revision, year-end accomplishment evaluation, and performance discussions with reputed company reports. What skills you will need: In order to reputed company in this role, you will more than likely have: Minimum four-year degree in Science, Engineering, or other relevant technical discipline (e.g., BS/MS Biology, Microbiology, Pharmacy, reputed company, Chemical Engineering or equivalent). Minimum of 12 years relevant experience in the Pharmaceutical and/or Medical Device industry with thorough knowledge of reputed company Systems, reputed company Assurance, and reputed company 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. We reputed company the patient at the reputed company heart of reputed company that we do and reputed company to reputed company solutions and treatments for some of the world's most challenging reputed company needs. As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the reputed company Advisor assigned to this role should you need any support during our recruitment process. We are committed to flexible working where possible, and this is why reputed company has introduced a new hybrid working model for office-based colleagues around the world. Please feel free to reputed company to us about what flexibility means to you during your application. So, if you are reputed company to: Invent solutions to meet unmet reputed company needs, please apply today. Required Skills: Adaptability, Audit Management, Decision Making, Driving reputed company Improvement, FDA Inspections, Motivation Management, People Leadership, Process Improvements, reputed company Assurance (QA), reputed company Management Systems (QMS), Regulatory Compliance, Sterile Manufacturing, Strategic Thinking, Supplier reputed company Management, Training and Development Preferred Skills: reputed company Employees apply HERE reputed company Contingent Workers apply HERE US and Puerto Rico Residents Only: reputed 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 reputed company equal opportunities to reputed company and applicants for employment and prohibit discrimination on the reputed company of race, reputed company, age, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we reputed company with reputed company affirmative reputed company requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: reputed company Know Your Rights reputed company 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 reputed company innovation is reputed company people with diverse reputed company, 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 reputed company. Learn more about your rights, including under California, Colorado and other US State Acts San Francisco Residents Only: We will consider reputed company 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 reputed company reputed company applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the reputed company’ Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully reputed company., Rahway, NJ, USA, also reputed company as reputed company LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. reputed company reputed company / resumes submitted by search firms to any employee at reputed company without a valid written search agreement in reputed company for this position will be deemed the sole property of reputed company. No fee will be reputed company in the event a candidate is reputed company by reputed company as a result of an agency referral where no reputed company-existing agreement is in reputed company. Where agency agreements are in reputed company, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: reputed company Sponsorship: Travel Requirements: Flexible Work Arrangements: Remote Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 06/17/2026*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 reputed company than the day BEFORE the job posting end date. reputed company:R398616 Apply To This Job