Senior Specialist, Quality Assurance - Hybrid

MSD in the UK; London; Hybrid; GBP 104,000 - 164,000; Full time

Job summary

An established industry player is seeking a Senior Specialist in Quality Assurance to oversee the regulatory compliance of clinical supplies. This role involves ensuring timely release of supplies for global clinical trials, collaborating with various departments to enhance processes, and maintaining high standards of quality assurance. The ideal candidate will possess a strong background in clinical trials, regulatory requirements, and problem-solving skills. Join a dynamic team dedicated to excellence in clinical development, where your contributions will directly impact the success of innovative research initiatives.

Qualifications

• 5 years experience in the pharmaceutical industry required.
• Strong understanding of quality assurance and regulatory requirements.

Responsibilities

• Ensure regulatory release of clinical supplies for global trials.
• Collaborate with various teams to improve the release process.

Skills

Clinical Trials Knowledge

Regulatory Compliance

Problem-Solving

Quality Assurance

Communication Skills

Education

Bachelor’s Degree in Scientific Discipline

Job description

Senior Specialist, Quality Assurance - Hybrid

Join to apply for the Senior Specialist, Quality Assurance - Hybrid role at MSD in the UK

Senior Specialist, Quality Assurance - Hybrid

Join to apply for the Senior Specialist, Quality Assurance - Hybrid role at MSD in the UK

Job Description

The Clinical Supplies Quality organization, within our Research & Development (R&D) Division, is responsible for assuring the reliable availability, quality and regulatory compliance of clinical supplies in support of the clinical development programs for the R&D portfolio to enable the execution of all clinical trials (including more than 300 Phase I-IV clinical trials run inhouse, 400+ outsourced trials, 200+ IIS clinical trials and 200+ External Collaborations across 60+ countries) in accordance with worldwide regulations, company policies and standard operating procedures.

Job Description

The Clinical Supplies Quality organization, within our Research & Development (R&D) Division, is responsible for assuring the reliable availability, quality and regulatory compliance of clinical supplies in support of the clinical development programs for the R&D portfolio to enable the execution of all clinical trials (including more than 300 Phase I-IV clinical trials run inhouse, 400+ outsourced trials, 200+ IIS clinical trials and 200+ External Collaborations across 60+ countries) in accordance with worldwide regulations, company policies and standard operating procedures.

The Clinical Trial Regulatory Release auditor will have responsibility for releasing supplies to support our global clinical trials, ensuring regulatory release activities are performed in a timely and compliant manner to meet the portfolio needs. This position will require close collaboration and partnership with Global Clinical Supply, Global Clinical Trial Operations, Global Regulatory Affairs and Quality functions supporting the clinical supply chain to develop, implement and enable country release activities.

Primary Activities Include, But Are Not Limited To

• Regulatory release of clinical supplies, ensuring compliance to applicable procedures to support global clinical trials.
• Assess Country specific requirements and conditions set forth by Health Authorities to ensure compliant release of clinical supplies
• Author/support the authoring of procedures
• Work closely with various business areas to ensure robust processing and continuous improvement throughout the end-to-end release process
• Collaborate with Global Development Quality (GDQ) to implement an agile, end-to-end release process designed to improve efficiency and ensure compliance.
• Assist in projects aimed at reducing processing cycle times, contributing to overall operational excellence
  
  

Required Experience And Skills

• Comprehensive understanding of Clinical Trials and regulatory requirements
• Exquisite sense of urgency coupled with the ability to independently manage multiple priorities
• Robust problem-solving abilities with a proactive approach to managing challenges
• Background in quality control, quality assurance, auditing, Global Clinical Trial Operations or regulatory affairs.
• Attention to detail, flexibility and an awareness of the end-to-end supply release process
• Demonstrated teamwork skills and ability to work independently
• Strong written and oral communication skills
  
  

Education/Experience

• Bachelor’s Degree in Scientific Discipline with 5 years relevant experience within the pharmaceutical industry
  
  

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

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, Monday - 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”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range

$104,200.00 - $163,900.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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 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)

No

Job Posting End Date

05/13/2025

• 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 R347176

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Quality Assurance, and Science

• Industries

  Biotechnology Research, Pharmaceutical Manufacturing, and Veterinary Services

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