Quality Assurance Manager - Pharmaceuticals

WuXi AppTec•Middletown, DE

About The Position

The Quality Assurance Manger will lead the implementation and maintenance of the Quality Management Systems (QMS) at our new manufacturing facility. This leadership role involves designing and implementing operationally and inspection-ready systems, directly supervising quality personnel, conducting and overseeing internal audits, managing regulatory and client audits, and interfacing with clients to drive commercial and compliance success. The role includes follow-up on audit findings via Corrective and Preventive Actions (CAPA), team development, training oversight, batch record review support, and product disposition decisions. The ideal candidate is a strategic, detail-oriented leader with strong pharmaceutical quality assurance experience, capable of building and guiding a team in a fast-paced, startup-like environment while ensuring strict adherence to GMP and regulatory requirements. Candidates must have deep knowledge of regulatory guidelines to guide compliant system and process development.

Requirements

Bachelor's degree in Pharmacy, Chemistry, Biology, Engineering, or a related scientific field.
Minimum of 10 years of experience in pharmaceutical quality assurance, preferably in various dosage forms such as solid oral dose and small molecule sterile injectables.
Proven experience in QMS implementation, internal auditing, and managing regulatory audits.
Strong knowledge of GMP, ICH guidelines, ISO, and ISPE guidelines.
Certifications in auditing and quality management from ASQ or other professional organizations.
Excellent analytical, problem-solving, and communication skills, with the ability to influence stakeholders at all levels.
Proficiency in quality management software and Microsoft Office Suite.
Ability to work independently and as part of a team in a regulated, high-pressure environment.
Willingness to travel occasionally for audits or training.

Nice To Haves

Experience in a greenfield manufacturing site startup.
Experience in OPEX and Lean Six Sigma concepts
Experience in OSD manufacturing processes.
Familiarity with aseptic processing and sterile product manufacturing.
Training certification (e.g., in GMP or quality systems).
Knowledge of risk management tools (e.g., FMEA)
Knowledge of quality engineering and statistical process control concepts.

Responsibilities

Directly supervise, mentor, and develop a team of quality professionals, including assigning tasks, conducting performance reviews, and fostering professional growth to build a high-performing quality function.
Lead the implementation of total quality management, approximately 40 operations and quality systems, at the new manufacturing site, including developing and documenting processes for solid oral dosage, API, and aseptic small molecule production to ensure compliance with FDA, EMA, and other regulatory bodies.
Review and approve facility, utility and equipment CQV documentation such as VMP, URS, FAT, SAT, turnover packages, installation/operation/performance qualifications, and process validations.
Conduct readiness inspections of manufacturing areas, equipment, computerized systems, and processes to identify and mitigate potential quality risks prior to operational startup.
Plan, execute, and report on internal audits to assess compliance with QMS standards, identifying areas for improvement and ensuring timely resolution.
Host and facilitate audits from regulatory authorities (e.g., FDA, EMA) and clients, preparing documentation, coordinating site tours, and responding to inquiries.
Manage the follow-up on audit findings, observations, and deviations through the CAPA process, including root cause analysis, action plan development, implementation, and verification of effectiveness.
Create and support employee training programs on quality systems, GMP, and related topics to foster a culture of quality and compliance.
Assist in the review of batch records for accuracy and completeness, contributing to product disposition decisions as needed.
Assist in all municipal, federal and foreign compliance matters to gain and maintain approvals for commercial GMP production.
Support deviation investigations and review and approve QMS documents such as change control, deviation reports, CAPA, continuous improvements, and effectiveness checks.
Collaborate with cross-functional teams (e.g., manufacturing, engineering, and regulatory affairs) to integrate quality principles into daily operations.
Maintain accurate records and documentation in compliance with data integrity standards.
Stay current with industry trends, regulatory updates, and best practices in pharmaceutical quality management.