Manager Quality - Pharma from Management Recruiters of Edison

Our client – a growing company with multiple plants in the US, needs a Manager of Quality at their plant expanding to manufacture pharmaceutical products. Excellent salary up to $120K+ Relocation Assistance + Full Benefit Package + 3 Weeks’ vacation.

Job Posting # 2642

Job Title: Manager Quality - Pharma                           Location:  Lawrence, KS                           

Compensation: Salary of $100K - $120K per year 

Relocation:  YES - Client offers relocation assistance and payments for expenses

Benefits:  Full package for medical, dental insurance, 401K + 3 Weeks’ Vacation + 13 days - PTO, etc.

This is a privately held company in business for 40 years with 300 people at manufacturing sites in CA, KS

Group Info:  Be part of the medical device and pharmaceutical contract manufacturing site with around 100+ employees and expected to grow to 150 people soon due to major expansion in Pharma manufacturing.

The new operation expansion is for Pharma - Blow Fill Cap – BFC of Sterile Solutions.

The Quality group has around 25 people from QC, QA, Quality, Validation, Compliance. This role will report to the Director of Quality.

This Manager will have a total of 14 people. 3 direct reports + Quality Supervisor and 10 quality inspectors under this supervisor for incoming, in process and final products inspections.

Job Summary:

• The QA Manager is responsible for providing comprehensive technical support and quality assurance oversight to meet good business practices and the requirements of applicable Health Authori

• Supports the manufacturing, testing, disposition, and distribution of all materials that company manufactur

• Ensures product(s) consistently meets our customer and regulatory requirem

• Responsible for the overall development, implementation, maintenance, and performance of the quality system.

• Works with other departments to ensure progress toward company goals while maintaining compliance with QSR requirem Monitors quality processes and collects metrics to document performance.

• Additionally, this position will drive day to day QA requirements for site readiness, the role will be involved in positioning projects with customers during the Business Development process as well as being involved in the actual project delivery ensuring that quality requirements are met as required by regulators and customer

Job Description: 

• Establishes, implements, and maintains quality management system.
• Ensures current quality management policy is in compliance with relevant regulatory agencies following laboratory protocol and procedu
• Liaison between Manufacturing and QA for executed Batch Record Review and flow of docum
• Reviews and dispositions production batch records for product releas Determines if records are compliant with internal and cGMP regulations.
• Reviews and approves GMP product lab
• Supports FDA/Regulatory inspection activities.
• Supports regulatory filing as need
• Collects and presents metrics to document performan
• Train staff as needed.
• Collaborates with other departments to address issues and meet deadlines.
• Participates in and/or lead project teams as a Quality representative.
• Provides support for internal and external audits.
• Influence and implement initiatives within QA to improve overall compliance and maintain inspection readiness.
• Develop, review, and approve protocols/strategies (validation, qualification, commission, et)
• Ensuring that the QA department is integrated in project delivery from project initiation to completion.
• Due to the nature of the development process and drugs/medical devices - the company environment is fast paced and constantly changing. The individual will need to have the ability to ensure that prioritizing, allocating and monitoring work across team members to meet customer deadlines is managed appropriately.
• Achieve throughput and turnaround targets on a project, monthly and annual basis, monitoring and reporting on the productivity of the team. Report performance against Key Performance Indicators (KPIs).
• Develop a collaborative, pragmatic culture that encourages colleagues to support each other in problem solving to achieve excellent and timely results for custom

Candidate Must Have:

• Bachelor’s Degree
• Min. 6 years of Quality experience in FDA regulated Pharma or Medical Devices
• Min. 3 years of Quality Management experience
• Excellent people, communication and management skills to create a team environment
• Good leadership skills to motivate plant personnel and gain their respect

• Working knowledge of 21 CFR Parts 210, 211 and 820 FDA complian
• Skills in Quality Management, Staffing, Management Proficiency, Coordination, Coaching, Developing Standards, Quality systems Improvement, Decision Making, Strategic Planning, etc.
• Technical knowledge of pharmaceutical manufacturing, validation, raw materials, analytical testing, and materials management is desirable.
• Able to work effectively in a customer service and business partner rol

Candidate Nice to Have:

• Technical degree in Science, Chemistry, Biology, Microbiology or Engineering

• Certified Quality Auditor certification, or equivalent.

• Experience with remediation of Quality systems in FDA 483, warning letter, or Consent Decree.
• Audit or inspection experience preferred.
• Startup or Small company experience working in a dynamic and hands-on role.
• Familiarity with Microsoft Project and project management principles.
• Knowledge of Sterile Aseptic Filling Operations
• Contract Manufacturing experience working closely with customers and clients

Keywords: BioPharma, Pharma, Quality, QC, QA, FDA, 483, Warning Letter, CMO, Sterile Aseptic, filling, FFS, Management, Validation, CDMO, Manufacturing, Plant