Senior Manager, Quality Assurance and Supply Chain

5 days ago

Billerica, Massachusetts, United States Sun Pharmaceutical Industries, Inc. Full time
Job Summary

As a Senior Manager, Inspection and Packaging, and Warehousing at Sun Pharmaceutical Industries, Inc., you will be responsible for executing plans, scheduling, and expediting the visual inspection, labeling, and packaging of parenteral pharmaceuticals and dermatological products to meet sales requirements according to current Good Manufacturing Practices (cGMPs) and following Standard Operation Procedures (SOPs).

This role will also involve managing the warehouse shipping/receiving team and overseeing all phases of the Change Control process for owned changes. Additionally, you will be responsible for hiring, training, managing, and motivating staff to meet production and warehouse demands.

Key Responsibilities
  • Directly oversee shift leads and floor personnel through regular presence on the floor in the inspection/packaging areas as well as the warehouse to improve safety, optimize quality, and elevate performance.
  • Manage all kit inspection, packaging, and labeling operations in accordance with direction from the Operations Director and commercial forecast.
  • Plan, lead, manage, prioritize, and organize work in the ILP and warehouse operations teams.
  • Work cohesively with the Sr. Production manager to ensure packaging area scheduling are in alignment.
  • Able to be a SME for Visual Inspection during FDA/Health Canada/EU inspections.
  • Assign daily duties to group to accomplish production goals utilizing personnel effectively.
  • Ensure all staff training and qualifications for Visual Inspection are up to date.
  • Resolve routine to complex inspection and packaging issues and/or equipment problems with staff and/or other departments in a timely fashion.
  • Revise batch records and standard operating procedures (SOP's) as needed to improve efficiency and quality of manufacturing/packaging process.
  • Use systems like SAP, Track-Wise, EDMS, and Master Control, etc.
  • Initiate/Author and be able to complete Deviations, Change Control, CAPA's, etc.
  • Update computer data for packaging department to record production inventory, results, dates, problems, etc.
  • Review all in-process documentation for accuracy.
  • Ensure proper operation of Inspection/Labeling/Packaging equipment.
  • Plan and order supplies for production to assure the timely completion of production goals.
  • Make recommendations on efficiency and cost as appropriate.
  • Work under minimal direct supervision, utilizing some standard procedures along with own judgment.
  • Prioritizes safety and maintains good housekeeping in the ILP working area and warehouse.
  • Oversee all phases of the Change Control process for owned changes.
  • Hire, train, manage, and motivate staff to meet production and warehouse demands.

Work Conditions:
  • Office
  • Shop/Shipping area
  • Controlled/Manufacturing area

Physical Requirements:
  • Stand, sit, walk, use hands and fingers to handle or feel, reach with hands and arms
  • Climb or balance, stoop, kneel, crouch or crawl, talk or hear, taste or smell
  • Close, color, and peripheral vision, depth perception, ability to adjust focus
  • Correctable 20/20 vision
  • Ability to visually inspect small products and print
  • Be able to multitask
  • Operate label application machinery, thermal transfer printer, computer, serialization, and heat sealing equipment
  • Operate computer/office machines
  • Proper gowning, Safety shoes, safety glasses, gloves
  • Lift up to 30 lbs.

Travel Estimate:
Up to 5%

Education and Job Qualification:
  • B.S. required
  • Must possess current, valid class D Driver's license
  • Ability to operate and maintain all process equipment
  • Familiarity with FDA cGMP, SOPs, and ISO standards
  • Knowledge of pharmaceutical labeling/packaging equipment and warehouse operations

Experience:
  • Minimum 8-10 years related experience with minimum 4-6 years in a supervisory and/or managerial role required
  • Direct experience with manual visual inspection for small volume parenteral required
  • Strong computer skills

Compensation and Benefits:
The presently-anticipated base compensation pay range for this position is $130,000 - $142,500 +15% bonus target. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental, and vision coverage; life insurance; disability insurance; 401(k) savings plan and company match; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

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