Job Description
A wonderful opportunity has arisen to join the Ballydine site as Associate Director Quality Assurance. Reporting to the Quality Director, the incumbent will work with the Quality Leadership team to ensure compliance with all regulatory requirements for Drug Substance (DS), Spray Dried Intermediate (SDI) and Drug product (DP) released to downstream customer. This is a permanent role with opportunities for some home working.
Role Responsibilities
- Provide Quality support to the Integrated Process Teams (IPT) to ensure the facility meets and operates to all Good Manufacturing Practice (GMP) requirements for development, clinical and commercial supply.
- Participate as a team member in the Documentation Review and Approval Process, Deviation Management Process, Quality Risk Management, Change Control Management and New Product Introduction.
- Support internal, customer and regulatory GMP audits of the plant. Act as lead auditor for internal walkdowns and systems audits to ensure compliance with cGMPs to maintain inspection readiness.
- Accountable for the development and performance of the team, providing input and coaching on professional development. Provide timely feedback and ensure that responsibilities are delivered following appropriate inclusion principles & behaviours.
- Lead and support Continuous Improvement of Quality and site processes.
Qualification Requirements
- Degree or post graduate qualification in Science, Pharmaceutical or Engineering field.
- Minimum of 5-year experience in the Pharma regulated industry with leadership experience. Clinical and commercial GMP experience preferred.
- Excellent knowledge of regulations and sources of regulatory information.
- Experience with regulatory inspections.
- Qualified Person qualification is an advantage.
- Experience in High Potency Manufacturing, Continuous Manufacturing, Spray Drying, Laboratory GMP and Project Management is desirable.
- Demonstrated continuous improvement mindset and capabilities.
- Dynamic individual with excellent organizational skills, who can effectively collaborate with cross functional teams.
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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not ApplicableShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Change Management, Change Management, Computer System Validation (CSV), Cross-Team Collaboration, Decision Making, Documentation Review, Driving Continuous Improvement, GMP Compliance, GMP Laboratory, IS Audit, Maintenance Management, Management Process, New Product Development, New Product Introduction Process, People Leadership, Performance Qualification (PQ), Pharmacy Regulation, Professional Development, Quality Assurance (QA), Quality Auditing, Quality Control Documentation, Quality Management, Quality Management Standards, Quality Management Systems (QMS), Quality Risk Management {+ 4 more}Preferred Skills:
Job Posting End Date:
06/30/2025*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.
