Quality Assurance Manager

Quality Assurance Manager Lexitas Pharma Services - 3.0 Erie, PA Job Details Full-time 1 day ago Qualifications Quality control corrective actions Regulatory inspections Record keeping Document review (document control) Management Procedural guides Pharmaceutical regulatory compliance Writing skills Engineering Compliance audits & assessments Corrective and preventive actions (CAPA) Quality management Implementing healthcare compliance training programs Risk mitigation strategy implementation 8 years Quality assurance audits Analysis skills ICH guidelines Policy & process development Bachelor's degree in engineering Clinical research compliance Bachelor's degree Certified Quality Auditor Typing Overseeing audit functions Continuous quality improvement (CQI) Training & development Root cause analysis Senior level Training Team motivation (leadership skill) Communication skills FDA regulations Full Job Description We're looking for purpose-driven, passionate individuals to join our team. From clinical to commercial to supporting functions, Lexitans believe in the common mission: to be the best ophthalmic product development organization to partner with. Overview The QA Manager ensures consistent quality standards, compliance and continuous improvement as well as provides hands-on support to ensure the site meets regulatory requirements, customer expectations and organizational goals. Responsibilities Establish and maintain QA policies, procedures and SOPs. Lead quality review meetings, ensuring alignment on metrics, issues and improvement plans. Ensure site compliance with relevant regulatory requirements. Lead internal and external audits across the site network. Maintain readiness for regulatory inspections, support site-level inspection teams and be QA Lead for regulatory inspections. Oversee CAPA, deviations management, change control and document control process at the site. Monitor and analyze quality metrics across the network to identify trends and areas of risk. Support root-cause analysis and problem-solving activities. Lead or support quality improvement projects, ensuring consistency in tools, methods and documentation. Facilitate training programs on quality principles, processes and compliance expectations. Identify and assess quality risks across the site network and develop risk mitigation strategies. Maintain network-wide risk registers and ensure proactive follow up on mitigation activities.

Requirements Education:

Required:

Bachelor's degree Engineering, Lifesciences or related discipline.

Experience:

8+ years of relevant life science industry experience, with a minimum of 5 years of GCP compliance in an FDA regulated environment. Strong knowledge of regulatory and industry quality standards. Previous experience hosting regulatory inspections and customer audits.

Certifications:

Preferred certifications:

Quality Auditor Skills:

Strong ability to motivate company personnel to adhere to quality policies and procedures. Solid independent thinking ability and demonstrated ability to discern multiple viewpoints. Good working knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations. Experience with Quality Management Systems (e.g., documentation and record management, change control, deviations, investigations, training and CAPA programs) Good analytical skills with the ability to evaluate data trends for lessons learned, required action, etc. Demonstrated ability to conduct root cause analysis and to prepare written remediation plans. Demonstrate process auditing and improvement skills and aptitude. Demonstrate ability to develop effective procedures and to write clear, consistent, thorough SOP's. Excellent verbal and written communication skills. One week per month onsite in Erie, PA Physical Requirements Position requires: ordinary ambulatory skills and physical coordination sufficient to move about conference or meeting locations as required; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. Lexitas Pharma Services, Inc., at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. Lexitas Pharma Services, Inc., at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.