Quality Manager - Pharmaceutical

Location

Lawrence, KS | United States

Job description

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

Job Posting # 2623

Job Title : Quality Manager - pharmaceutical

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, 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 3 direct reports – Tech Writer, Regulatory Affairs, Admin person & work closely with a Sr. Quality consultant



Note 1: This new quality group will be mostly in charge of Supplier Quality Management

Job Summary:

• The Quality Manager is responsible for supplier quality management and change management for all site facilities, utilities, equipment, and documentation.
• Responsible for quality oversight of changes to product components, containers, closures, and finished products. Responsibility includes continuous efforts to upgrade and improve the interface in current systems and conversion to new electronic systems upon approval from site and Company management.
• Responsible for ensuring the effectiveness and continuous improvement of quality relationships with active pharmaceutical ingredients (API), container-closure, packaging materials and any other Business Unit suppliers. In addition, the position is also responsible for overseeing the integration of new products and services to ensure compliance with all applicable regulations and standards.  This position assesses suppliers’ capability of meeting regulatory and GMP manufacturing standards through the planning, execution, tracking, and completion of key supplier audits. 

Job Description:

• Responsible for supplier quality including auditing, quality agreements, customer complaints, and supplier qualification.
• Management of the change management systems . Ensure that the change control and document management quality systems are consistent with Company policies, procedures, and cGMPs.
• Responsible for conducting Change Control Review Board (CCRB) on a specified frequency to review and make decisions on change control deliverables.
• Responsible for resolution for change control Make and guide decisions on classifications of changes and change control deliverables required to complete a required change.
• Provide oversight of electronic systems for change control activities. Make and guide decisions on changes and system requirements for product lifecycle management related to change control, product
• Represents the Company as the Subject Matter Expert for pharmaceutical supplier quality during regulatory inspections, submissions, and assessments.
• Serves as the Quality Authority for the selection, development, and approval of new suppliers for new product introductions and assures that strategic initiatives are met.
• Executes and manages Supplier Quality Agreements and amends as needed.
• Conducts internal and external audits.
• Manages the Approved Supplier List , including collecting and reviewing supplier certification statements/surveys to maintain compliance with company procedures, regulatory agency and compendial requirements
• Assesses supplier exception reports, proposed supplier changes and notifications, to determine the impact on the Company. When applicable, work with the suppliers and determine resolution.
• Manages supplier investigations, CAPAs, complaints , and risk mitigations for commodities that do not meet Company specifications.
• Assists in the creation of annual audit schedules (internal and external)
• Provides support for market field actions such as product recalls, field alerts, and market withdrawals.
• Establish and maintain budgets and expenditures for the area of responsibility.
• Reviews and approves supplier validation and qualifications packages when applicable. 

Candidate Must Have :

• Bachelors Degree
• Min. 5 years of Quality experience in FDA regulated Pharma or Medical Devices
• Min. 2 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

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

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 environment
• Startup or Small company experience working in a dynamic and hands-on role.
• Knowledge of Sterile Aseptic Filling Operations
• Contract Manufacturing experience working closely with customers and clients

Keywords: BioPharma, Pharma, Quality, ISO, FDA, 483, Regulatory, QA, QC, CMO, Sterile Aseptic, filling, BFC,

Job tags

Salary