Quality Assurance Manager

POSITION DESCRIPTION

Role / Position Title - Quality Assurance Manager

Department/Function - Quality

Country - USA

Region / City (within Country) - Allentown, PA

FLSA (Exempt/Non-Exempt) - Exempt

Hours - 8 a.m. to 5 p.m. in office 5 days per week

OVERALL JOB RESPONSIBILITIES

Note: These statements are not intended to be an exhaustive list of all responsibilities and duties.

• Handling QMS (Quality Management System) activities which includes:
• Handling of Deviations, Investigations, CAPA, Change Controls
• Preparing and reviewing SOPs related to Quality Assurance
• Reviewing SOPs related to other departments
• Ensuring proper documentation control activities are being followed per cGMP requirements
  • Coordinating with manufacturing sites in regards to QMS activities
  • Review and maintaining existing Quality System and ensuring compliance to Agency Regulations / cGMP expectations
• Handling employee training and ensure training is carried out and completed per current procedures and regulations
• Handling of product quality complaints
  • Handling of FAR, Recalls and their monthly submissions to Agency
• Handling of CMO/Vendor activities which includes:
• Preparing and reviewing of Quality Agreements with CMO and Vendors
• Ensure that Quality Agreements are being followed
• Reviewing and approving CMO QMS documents like Deviations, investigations, protocols, change controls etc.
• Handling of product quality complaints for CMOs, coordinating with CMOs and Review and approval of CMO product complaints
• Ensure that CMO/Vendor audits are carried out per audit schedule
• Perform vendor audits of existing and new CMO/CPO/CTL/Vendors. Initiation, Review and Approval of workflows/Request related to SAP Masters
• Preparing/Review of audit reports and carry out follow-ups regarding audit report response from CMO/vendor and ensure adequate implementation of proposed CAPAs by CMO/Vendors.
  • Coordinate with CMO sites for ongoing activities/updates/projects
• Handling of Controlled Substance activities, which includes:
• Receiving and storage of controlled substance at Glenmark Mahwah location per current Procedures and DEA regulations
• Coordinating with Sales and Marketing for fulfillment of customer orders, processing, shipping and documentation per current DEA regulations,
• Handling controlled substance periodic inventory counts
• Handling destruction of controlled substances per current procedures and DEA regulations
• Handling of ARCOS reporting and state reporting
• Ensure all the activities related to controlled substances are carried out per current DEA State and Federal regulations.
  1. Responsible towards cross-departmental projects in providing quality/compliance oversight.
  2. Handling regulatory inspections (FDA, DEA, VAWD/NABP, NJDOH, etc.) and follow up reports/ response.
• Handle/carry out other QA departmental activities/projects as assigned by supervisor

KNOWLEDGE, SKILLS AND ABILITIES

Education

• Bachler’s degree (or equivalent) in Science

Experience

• 5-7 years of experience in pharmaceuticals industry, preferably in Quality Department

Knowledge and Skills (Functional / Technical)

• Well-versed with current FDA and DEA regulations
• Proficient with MS Office (Word, Excel, PowerPoint and Outlook)
• SAP or any other ERP system

Physical demands and abilities

• The incumbent typically works in an office environment and uses a computer, telephone and other office equipment as needed to perform duties.
• The noise level in the work environment is typical of that of an office
• Incumbent may encounter frequent interruptions throughout the work day.
• The employee is regularly required to sit, talk, or hear; frequently required to use repetitive hand motion, handle or feel, and to stand, walk, reach, bend or lift up to 20 pounds

ABOUT GLENMARK

Glenmark is a global leader in the development and commercialization of generic drugs of the highest quality and value. We help to improve peoples’ lives every day by helping to reduce their healthcare costs while delivering high-quality medicines.

Established in 2003 as a North American subsidiary of Glenmark Pharmaceuticals, we launched our first generic product in January 2005 and quickly emerged as one of the leading generic organizations in the United States.

Today we have a diverse business. As a global leader in generics, we are leveraging our industry expertise and success to fuel extensive research to expand development in specialty branded products innovative products that are intended to have a major impact on how people live.

BENEFIT HIGHLIGHTS

• Paid time off
• 401k plus company match
• Company paid health benefits
• Dental
• Vision
• Onsite access to company gym
• Corporate Discount Program
• Paid Employee Referral Program
• EAP – Employee Assistance Program
• Accident Insurance
• Critical Illness Insurance
• Commuter Accounts
• Short-Term Disability
• Life and AD & D Insurance
• Whole Life Insurance
• Pet Insurance and so much more!

This job description is to serve as a guide. It is intended to be flexible and will continue to evolve over time with business needs and demands and may be updated periodically and at the Company’s discretion. Nothing in this position description changes or is intended to change the employment at-will relationship with the Company. Employment at-will means that an employee or the Company may terminate the employment relationship at any time, for any reason or no reason at all, with or without notice.

Glenmark Pharmaceuticals Inc USA is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.