Associate Director, Quality Control

Job Description

An exciting opportunity to join our Carlow site as an Associate Director of Quality Control. The Associate Director of Quality Control (QC) will play a pivotal leadership role, overseeing the Bioassay and Chemistry teams responsible for testing, stability, and release samples for the site and supporting partner and sister sites.

This position also provides expert analytical support, including analytical investigations and analytical transfers, while driving compliance, operational excellence, and continuous improvement across the QC function.

Bring energy, knowledge, innovation, and leadership to carry out the following:

• Leading, developing, coaching, and supporting managers and senior team members within the quality control department.
• Align site deliverables with department goals and objectives.
• Ensure lab KPIs are achieved to support supply targets.
• Oversee laboratory readiness for new product introductions.
• Ensure compliance with global and regulatory requirements, promoting a strong culture of safety and quality.
• Manage QC-related issues, including atypical results, out-of-specification investigations, and significant quality investigations.
• Drive continuous improvement initiatives, including the adoption of digital technologies to improve efficiency.
• Collaborate with cross-functional site teams, including QC Operations, IPT, Automation Compliance, Regulatory, Technical Engineering, and C&Q teams, to ensure regulatory requirements are met.
• Manage laboratory budget and costs, ensuring financial targets are achieved.
• Liaise with global partners on technical transfer and validation strategies.
• Implement and sustain continuous improvement programmes, Lean principles, and Lean thinking.

Skills you will bring:

• Strong analytical aptitude and critical thinking skills.
• Ability to apply key scientific and technical concepts effectively.
• Proven ability to develop talent through strong mentoring and coaching.
• In-depth knowledge of GMP and GLP regulations.
• Knowledge of analytical validation and transfer requirements.
• Strong Lean Six Sigma experience.
• Third-level qualification in a science-related discipline, ideally Biochemistry, Chemistry, Biosciences, or equivalent.
• Analytical testing experience in a pharmaceutical laboratory.
• 10+ years’ experience in the pharmaceutical industry, including significant leadership experience and front-line supervisory experience in an operations environment.

Our facility in Carlow site broke ground in 2008 and is a filling site for the launch and commercial supply of vaccines, biologics and small molecule drug product. Since its initial launch, the site has attracted significant internal investment and is now home to a number of state-of-the-art production facilities, laboratories and temperature-controlled warehousing units. The Carlow site is a significant employer in the South East region and attracts high performing talent through close collaborations with universities and colleges in the region.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare 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 Talent Acquisition 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 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.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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.