Sr Manager - Quality Testing

ESSENTIAL FUNCTIONS:

• Ensure key turnaround timelines for customer service and compliance requirements are achieved

• Manage stability testing to achieve 100% on-time analysis for all stability protocol testing intervals

• Serve as the primary liaison for method transfers into the QC organization

• Accomplishes results through subordinate managers, supervisors, exempt specialist employees and non-exempt employees.

• Provide overall leadership to QC groups regarding cGMP compliance improvement and enhancement

• Serve as the Subject Matter Expert during compliance audits

• Study and improve various Quality processes through increased efficiency or process flow using Lean Manufacturing and/ or Six Sigma philosophy of operation

• Drive Quality consistency through revising or combining various analytical methods to ensure adequacy and quality with special emphasis on actual utility of methods under normal QC conditions

• Work with all Quality managers, supervisors and analysts to address any laboratory concerns regarding safety, methods, procedures, or operation

• Act as a liaison between the labs and manufacturing/ R&D in implementing special projects, production campaigns, or assist with validations or method transfers

• Works with various reports and QC groups to ensure compliance to Environmental Health and Safety and departmental safety requirements and provide proactive leadership toward continuous improvement of safety operations in our laboratories

• Ensure compliance with and oversee compendia affairs for SpecGx

MINIMUM REQUIREMENTS:

Education:

BS in Chemistry, Chemical Engineering, related science or equivalent combination of education, experience, and competencies.

Experience:

Minimum of 15 years related experience in Quality with 10 years management experience required.  Proven personnel and project management history.  Complete knowledge of pharmaceutical regulations including current GXP, GLP, or GMP requirements.

Preferred Skills/Qualifications:

• Excellent communication and leadership skills. 

• Ability to work in and promote a team environment. 

• Working knowledge of Six Sigma and/or Lean manufacturing tools.

• Complete understanding and application of principles, concepts, practices, and standards within discipline. 

• Ability to lead and influence people. 

• Understanding of basic statistical principles, expert knowledge of validation principles, techniques, and regulatory expectations.

• Knowledge of US and International pharmaceutical manufacturing regulations.

Other Skills:

• Exercises considerable latitude in determining technical objectives of assignment

• Completed work is reviewed for desired results from a relatively long-term perspective

• Bias toward change, management of change, and achievement of results

COMPETENCIES:

Decision Quality, Developing Direct Reports, Managing Diversity, Learning on the Fly, Managerial Courage, Organizing, Priority Setting, Problem Solving, Building Effective Teams         

RELATIONSHIP WITH OTHERS:

Reports to the Sr Director, Quality and Regulatory Affairs.  Manages group of exempt direct reports.  Develops strategic objectives for groups managed.  Contact with FDA as subject matter expert during site inspections.  Regular contacts including Logistics, Marketing, R&D, Site Production Leaders, HSE, and DEA.

WORKING CONDITIONS:

• 25% Laboratory exposure to plant products, solvents, reagents, some of which are hazardous or potent compounds

• 75% Office environment which requires sitting for long periods of time and computer use.

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills require