Quality Control (Qc) Manager - Pharmaceutical

Our client – a growing company with multiple plants in the US, needs aQuality Control Manager at their plant expanding to manufacture pharmaceutical products. Excellent salary + Annual Bonus + Relocation + Full Benefit Package.

Job Title: QC Manager – Pharma Manufacturing

Location: Lawrence, KS

Compensation: Salary up to $120KBase + 15% Annual Bonus Target

Relocation:YES - Client offers relo assistance – negotiated amount for reasonable moving expenses – receipts submitted for reimbursement and processed through payroll.

Benefits: Full package for medical, dental insurance, 401K, etc.

Our client is a privately held company with manufacturing sites in CA + KS with around 300 people

Group Info: Be part of the Medical device and Pharmaceutical contract manufacturing site with around 120+ employees and expected to grow to 150 people soon due to major expansion in Pharma manufacturing.

The new operation expansion is for Pharma Fill Finish Seal – FFS of Sterile Aseptic liquids.

This Quality group has around 25 people from Quality Control, Quality Assurance, Compliance.

This role will be responsible for the QC Lab and staff of 3 Leads and around 12 people and will report to the Director of Quality.

Job Summary:

• The Quality Control Manager develops and deploys the quality system for a small to mid-size plant manufacturing Medical Devices and Pharma Biologics, while assuring systems and procedures for regulatory compliance are established and deployed.

Job Description:

• 40%: Provide department management / supervision and leadership functions.

• 40%: Develop and strategically implement QC system development, QC process improvement and support projects

• 20%: Interface with manufacturing, corporate quality, engineering, safety, etc.
• Ensures that Quality testing strategies for raw materials, intermediates, bulks, packaging components, and finished products are aligned with internal and customer requirements. Leads the development of all documentation that describes testing strategies.

• Responsible for the management of the plant QC laboratory operations and testing for all finished product, intermediates, stability, consumer complaints, and raw materials tested in the laboratory.
• Manages overall coaching, training, development, and succession plans for the team

Candidate Must Have:

• Bachelors of Science in Chemistry or Microbiology or Engineering or related degree
• Min. 5 years of QA/QC experience
• Min. 3 years of Quality Management experience in the Pharma Industry
• Excellent people, communication and management skills to create a team environment
• Good leadership skills to motivate plant personnel and gain their respect

• Skills in Quality Management, Staffing, Management Proficiency, Coordination, Coaching, Developing Standards, Quality systems Improvement, Decision Making, Strategic Planning, etc.

• Knowledge of Sterile Aseptic Filling Operations

Candidate Nice to Have:

• Advanced degree or an MBA
• Experience with remediation of Quality systems in FDA 483, warning letter, or Consent Decree environment
• Startup or Small company experience working in a dynamic and hands-on role.
• Contract Manufacturing experience working closely with customers and clients

Keywords: BioPharma, Pharma, Quality, ISO, FDA, QA, QC, CMO, Sterile Aseptic, filling, FFS,