Job description

QA Manager, Documentation Systems

Global Pharmaceutical CDMO has a new opportunity for a QA Manager to join their dynamic & growing team. They offer a competitive compensation and benefits package as well as a friendly work culture.

The QA Manager provides leadership and guidance for the department, works to improve core processes, and manage projects. Ensure the staff is qualified in all quality area functions and that the QMS is maintained to applicable GMP requirements.

• Identify areas of continuous improvement within the Quality department and in the Quality Management System.
• Evaluate metrics for trends to better focus on areas requiring improvement. Develop goals for the Quality Assurance team to drive improvement and monitor for effectiveness.
• Develop and perform training for the Quality team as well as other departments in areas of the QMS and GMP requirements.
• Support the Quality teams in regard to projects including but not limited to commercial and clinical batches, Operational, QC, and QMS projects
• Lead and support with customer requests, quality events, QTAs, and complaints.
• Maintain an electronic documentation control system assuring all documents are current. Act as the Ensur system administrator.
• Support the teams as the system SME and/or administrator for creating CAPAs, change controls, deviations, and laboratory investigations.
• Exhibit strong communication and problem solving skills while leading the Quality Assurance department toward company goals and objectives.
• Provide guidance and leadership to the QA Specialists with input into their performance and goals
• Provides compliance support and expertise for QA department
• Supports the execution of audit readiness program to ensure compliance ready state at all time to Customer and Regulatory audits.
• Maintains tracking mechanisms to support various QA related metrics
• Continuously monitors and reviews QA systems and procedures for adherence to regulatory compliance, quality improvements, efficiency and industry best practice
• Participates in site quality and process improvement initiatives. Represents QA on site project teams
• Effectively lead team to deliver goals/results. Provides coaching and the necessary resources to area management to meet department objectives
• Conducts interviews and hires qualified candidates to fill open technical and support positions
• Conducts performance and development reviews
• Provides direction and leadership for the QA team in compliance, systems, commercial, pre commercial processes, support for development, manufacturing and supply chain operations.
• Develops and manages daily work schedule for QA Specialists to meet QA deliveries schedules and needs.
• Ensures QA documentation and batch release is completed by due dates and project timeline.
• Leads the design, implementation and continuous improvement of QA Operations, Systems and Compliance to promote efficient and compliant operations
• Provides support for implementation of new and key process optimization.

QUALIFICATIONS:

• Bachelor degree or higher in relevant scientific quality assurance/technical field and 5 years’ experience in a Pharmaceutical Manufacturing environment
• Ability to organize time for multiple tasks (major projects and daily functions)
• Good written, verbal and interpersonal communication skills
• Proficient computer skills, such as Microsoft Office, including Teams
• Leadership skills: Building the best team; business insight; strategic mindset; problem-solving; resource management
• 7+ years’ experience in a Pharmaceutical Manufacturing Quality role.

Job Type: Full-time

Pay: $110,000.00 - $120,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Retirement plan
• Tuition reimbursement
• Vision insurance

Schedule:

• Day shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

Work Location: In person

www.randomorbitinc.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, www.randomorbitinc.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, www.randomorbitinc.com is the ideal place to find your next job.