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Quality Compliance Manager

Department: Quality

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About the Job

The Quality Compliance Manager is responsible for overall compliance of site with respect to Quality systems, Standard Operating Procedures, CFR guidelines, DEA guidelines, DSCSA guidelines, Internal and External audits etc.

Job Responsibilities

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

+ Handling of Change controls/ Deviations/ Incidents/ CAPA/Risk Assessment/ Product Quality Complaints etc., which includes initiation to closure, effectiveness and trending.

+ Maintenance of an electronic tracking tool for oversight on key quality/ other systems and reporting to management as needed.

+ Handling of DQRS (Drug Quality Reporting System) cases, coordinating with manufacturing sites for investigation and Regulatory Affairs for arranging more information/ samples from FDA.

+ Managing Quality Management Review meetings, circulating minutes of meeting, coordinating with stakeholders for completion/ implementation of identified/ assigned tasks during QMR meeting.

+ Handling of Field Alert Reports and Product Recalls, making sure no delay in submission to FDA per defined timeline. After initial submission, keeping track of all follow up FARs, final FARs, recall monthly updates and closure of recalls.

+ Handling of Training Management, making sure training SOP is being followed by all other departments, helping other departments for training identification, training execution, and training to new starters & refresher trainings etc. Handling of training software.

+ Ensuring DSCSA compliance is maintained for Rx pharmaceuticals drug products.

+ Handling of Internal and External audits, preparing response, coordinating with cross-functional team members for timely implementation and ensuring compliance.

+ Handling of SOPs, keeping track of due dates and notify stakeholders for the review and revision of the SOPs prior to due date. Making sure SOPs are made effective after completion of required percentage of training.

+ Maintaining documentation room and ensure that documents are stored and archived per retention policy and making sure destruction is completed after retention period.

+ Maintaining all QMS logs, keeping track of due dates, guide/ support stakeholders for timely closure of QMS events.

+ Handling of documents/ SOPs/ protocols and logbooks issuance and archival etc.

+ Mentor other staff members tasked with CAPA management activities

+ Interact with subject matter experts and quality representatives in different functions to support the implementation of processes and systems to improve quality management and business efficiency.

+ Integrating the domain specific aspects in the integrated quality management system and contributing to shared approaches and systems that serve all quality domains wherever useful and feasible.

+ Act as subject matter expert in the implementation, maintenance and improvement of electronic systems for training and quality document management.

+ Handling of Controlled substance activities, Federal and State ARCOS reporting.

+ Support other functions/ projects per business requirement.

Qualifications

Education

+ Bachelor-s degree in a relevant scientific discipline or equivalent work experience.

Experience

+ Approximately 5 - 7 years in a similar role, with experience of working to two or more GXPs in a pharmaceutical or biotech company.

+ Experience in the wide spectrum of pharmaceutical company activities.

+ Demonstrate excellent problem solving skills, a proactive approach and the ability to make sound decisions on a regular basis and to communicate these clearly

+ Full knowledge of the interactions required by the Quality Compliance Manager within and outside of the Quality folks; a good knowledge of the responsibilities of those departments with whom the Quality Compliance Manager will interact

+ Comprehensive knowledge of two or more GXPs, in-depth knowledge of EU and US FDA regulatory standards, knowledge of regulatory standards in other counties desirable

Knowledge and Skills

+ Fluent in English.

+ Must be able to work in a multicultural, international environment and be prepared to travel, with a proactive approach to building positive and productive working relationships with colleagues globally

+ Methodical with strong attention to detail

+ Strong organizational skills with a flexible approach, able to adapt to changing situations with excellent problem solving skills and a willingness to take ownership of decision-making

+ A professional approach at all times

+ Willingness and ability to challenge the views of others including those in more senior positions within the Company

+ Excellent presentation, written and verbal communication skills, capable of interfacing with all levels in the company and stakeholders and with internal and external customers

+ An engaging, assertive nature with excellent inter-personal skills.

+ A motivated self-starter, self-reliant and a strong, co-operative proactive team player capable of working in global teams, with strong influencing and negotiating capability, persistence and a strong determination.

+ Knowledge of DSCSA & DEA guidelines

+ SAP, Track Wise, Training software and/or other QMS tools/ software

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 workday.

+ The incumbent 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

Compensation and Benefits

Salary Range - $90,000 - 120,000

The compensation range provided reflects the expected base compensation only and does not include potential bonuses, incentive plans, or benefits. An individual-s final compensation offer will be based on a variety of factors, including but not limited to education level, relevant experience, training, and geographic location.

Benefits include:

+ Paid time off

+ 401k plus company match

+ Company paid health benefits

+ Dental

+ Vision

+ Onsite access to company gym

+ Paid Employee Referral Program

+ EAP - Employee Assistance Program

+ Accident Insurance

+ Critical Illness Insurance

+ Short-Term Disability

+ Life and AD & D Insurance

+ Whole Life Insurance

+ Pet Insurance and so much more!

About the Company

Glenmark is a global leader in the development and commercialization of generic drugs of the highest quality and value. We help to improve people-s 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.

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 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.

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