What are the responsibilities and job description for the Senior Director of Quality Compliance position at Aurobindo Pharma USA, Inc.?
Division Overview
Aurobindo Pharma USA, Inc. is a generic pharmaceutical manufacturer and distributor and is a wholly owned subsidiary of Aurobindo Pharma Limited, a leading generic pharmaceutical company based in India. Headquartered in HITEC City, Hyderabad, India, founded in 1986 and becoming a public company in India in 1992. Aurobindo Pharma USA, Inc. is committed to delivering a broad portfolio of quality, affordable generic pharmaceuticals to pharmacists and patients. Aurobindo Pharma USA, Inc. adds value through superior customer service in the distribution of a broad line of generic pharmaceuticals, leveraging vertical integration and efficient controlled processes. Aurobindo has business operations in more than 125 countries around the world. Aurobindo is a global pharmaceutical company with a broad portfolio of generic drugs that includes more than 180 product families and 450 individual product packages. Aurobindo markets over 80% of the top 100 most prescribed products in the world. In past years, Aurobindo has received more ANDA approvals than any of our competitors. Aurobindo is now ranked 2nd among pharmaceutical companies based on Total Prescriptions Dispensed. (We were #27 in 2010).
Job Overview
The Senior Director of Quality Compliance holds second level responsibility for quality compliance to all applicable cGMP regulations pertaining to all the markets currently being served by the operations functioning within said region. Actively provides guidance to multiple departments and facilities across Aurobindo Pharma USA, Inc. and its subsidiaries regarding their compliance with all applicable Corporate Quality and Regulatory Agency procedures, policies and regulations. This role is directly involved in assisting the Dept Head with corporate procedures and policies to help ensure that all products and / or materials are produced / tested / released strictly under cGMP conditions and the appropriate disposition of the same is taken per all applicable requirements.
Responsibilities
Helps to ensure cGMP compliance for operations within his / her regional oversight and provide Subject Matter Expertise (SME) guidance to meet regulatory requirements when needed. Assist with Regulatory Agency Inspections for operations (of oversight). Assists with investigations / resolutions of Market Complaints (along with any associated Field Alert Reports and / or Market Recalls) related to products from operations (of oversight). Assists with developing, implementing and maintaining Quality Assurance systems as well as conducting periodic reviews of these systems and implement Corrective Actions / Preventative Actions (CAPA) as appropriate. Assist with the responsibility for training needs of staff working within the region as necessary / applicable. Responsible for audit function(s) and take appropriate action(s) to assure compliance. Working in partnership with Development and Manufacturing (as well as other functions) to design processes and procedures related to Quality Assurance and Compliance activities that enhance cGMP operations and their continuous improvement. Annual performance assessment of Quality / Compliance staff working within the region. Will Assist department head with all Quality / Compliance matters within the region pertaining to all Regulatory, Customer and / or Vendor Audits. Actively implements best industry practices (i.e., electronic enterprises, etc.).
Qualifications - Skills & Requirements
Experience as a site quality head, in a senior role in central quality, or experience working at FDA is highly desirable. Position requires the ability to engage in an effective and collaborative manner across business units within US region and India. Periodic travel within US and territories (<15%) and international travel (<5%) will be required.
Education & Experience
Minimum of 10-15 years of experience in a Regulated and /or pharmaceutical industry within the Quality Assurance / Quality Control environment. Minimum of 10-15 years of experience in Quality Management Leadership roles, Assisting with multi-site operations / compliance activities across geographic regions. Minimum of bachelor’s degree in biology, Chemistry, Biochemistry, Pharmacy or ‘Related Field’ (can be multiple degrees that encompass multiple scientific disciplines and / or MS/PhD in one). (or equivalent experience) Additional postgraduate education is beneficial. Direct experience in engaging with FDA through field inspections is highly desirable
Physical Requirements
OFFICE POSITION - While performing the duties of this job the employee is required to:
No Additional Requirements Blood/Fluid Exposure Risk Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment., Experience as a site quality head, in a senior role in central quality, or experience working at FDA is highly desirable. Position requires the ability to engage in an effective and collaborative manner across business units within US region and India. Periodic travel within US and territories (<15%) and international travel (<5%) will be required., Helps to ensure cGMP compliance for operations within his / her regional oversight and provide Subject Matter Expertise (SME) guidance to meet regulatory requirements when needed. Assist with Regulatory Agency Inspections for operations (of oversight). Assists with investigations / resolutions of Market Complaints (along with any associated Field Alert Reports and / or Market Recalls) related to products from operations (of oversight). Assists with developing, implementing and maintaining Quality Assurance systems as well as conducting periodic reviews of these systems and implement Corrective Actions / Preventative Actions (CAPA) as appropriate. Assist with the responsibility for training needs of staff working within the region as necessary / applicable. Responsible for audit function(s) and take appropriate action(s) to assure compliance. Working in partnership with Development and Manufacturing (as well as other functions) to design processes and procedures related to Quality Assurance and Compliance activities that enhance cGMP operations and their continuous improvement. Annual performance assessment of Quality / Compliance staff working within the region. Will Assist department head with all Quality / Compliance matters within the region pertaining to all Regulatory, Customer and / or Vendor Audits. Actively implements best industry practices (i.e., electronic enterprises, etc.).
Aurobindo Pharma USA, Inc. is a generic pharmaceutical manufacturer and distributor and is a wholly owned subsidiary of Aurobindo Pharma Limited, a leading generic pharmaceutical company based in India. Headquartered in HITEC City, Hyderabad, India, founded in 1986 and becoming a public company in India in 1992. Aurobindo Pharma USA, Inc. is committed to delivering a broad portfolio of quality, affordable generic pharmaceuticals to pharmacists and patients. Aurobindo Pharma USA, Inc. adds value through superior customer service in the distribution of a broad line of generic pharmaceuticals, leveraging vertical integration and efficient controlled processes. Aurobindo has business operations in more than 125 countries around the world. Aurobindo is a global pharmaceutical company with a broad portfolio of generic drugs that includes more than 180 product families and 450 individual product packages. Aurobindo markets over 80% of the top 100 most prescribed products in the world. In past years, Aurobindo has received more ANDA approvals than any of our competitors. Aurobindo is now ranked 2nd among pharmaceutical companies based on Total Prescriptions Dispensed. (We were #27 in 2010).
Job Overview
The Senior Director of Quality Compliance holds second level responsibility for quality compliance to all applicable cGMP regulations pertaining to all the markets currently being served by the operations functioning within said region. Actively provides guidance to multiple departments and facilities across Aurobindo Pharma USA, Inc. and its subsidiaries regarding their compliance with all applicable Corporate Quality and Regulatory Agency procedures, policies and regulations. This role is directly involved in assisting the Dept Head with corporate procedures and policies to help ensure that all products and / or materials are produced / tested / released strictly under cGMP conditions and the appropriate disposition of the same is taken per all applicable requirements.
Responsibilities
Helps to ensure cGMP compliance for operations within his / her regional oversight and provide Subject Matter Expertise (SME) guidance to meet regulatory requirements when needed. Assist with Regulatory Agency Inspections for operations (of oversight). Assists with investigations / resolutions of Market Complaints (along with any associated Field Alert Reports and / or Market Recalls) related to products from operations (of oversight). Assists with developing, implementing and maintaining Quality Assurance systems as well as conducting periodic reviews of these systems and implement Corrective Actions / Preventative Actions (CAPA) as appropriate. Assist with the responsibility for training needs of staff working within the region as necessary / applicable. Responsible for audit function(s) and take appropriate action(s) to assure compliance. Working in partnership with Development and Manufacturing (as well as other functions) to design processes and procedures related to Quality Assurance and Compliance activities that enhance cGMP operations and their continuous improvement. Annual performance assessment of Quality / Compliance staff working within the region. Will Assist department head with all Quality / Compliance matters within the region pertaining to all Regulatory, Customer and / or Vendor Audits. Actively implements best industry practices (i.e., electronic enterprises, etc.).
Qualifications - Skills & Requirements
Experience as a site quality head, in a senior role in central quality, or experience working at FDA is highly desirable. Position requires the ability to engage in an effective and collaborative manner across business units within US region and India. Periodic travel within US and territories (<15%) and international travel (<5%) will be required.
Education & Experience
Minimum of 10-15 years of experience in a Regulated and /or pharmaceutical industry within the Quality Assurance / Quality Control environment. Minimum of 10-15 years of experience in Quality Management Leadership roles, Assisting with multi-site operations / compliance activities across geographic regions. Minimum of bachelor’s degree in biology, Chemistry, Biochemistry, Pharmacy or ‘Related Field’ (can be multiple degrees that encompass multiple scientific disciplines and / or MS/PhD in one). (or equivalent experience) Additional postgraduate education is beneficial. Direct experience in engaging with FDA through field inspections is highly desirable
Physical Requirements
OFFICE POSITION - While performing the duties of this job the employee is required to:
- Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment
- Specific vision abilities required by this job include close vision requirements due to computer work
- Light to moderate lifting is required
- Moderate noise (i.e. business office with computers, phone, and printers, light traffic).
- Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. Additional
No Additional Requirements Blood/Fluid Exposure Risk Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment., Experience as a site quality head, in a senior role in central quality, or experience working at FDA is highly desirable. Position requires the ability to engage in an effective and collaborative manner across business units within US region and India. Periodic travel within US and territories (<15%) and international travel (<5%) will be required., Helps to ensure cGMP compliance for operations within his / her regional oversight and provide Subject Matter Expertise (SME) guidance to meet regulatory requirements when needed. Assist with Regulatory Agency Inspections for operations (of oversight). Assists with investigations / resolutions of Market Complaints (along with any associated Field Alert Reports and / or Market Recalls) related to products from operations (of oversight). Assists with developing, implementing and maintaining Quality Assurance systems as well as conducting periodic reviews of these systems and implement Corrective Actions / Preventative Actions (CAPA) as appropriate. Assist with the responsibility for training needs of staff working within the region as necessary / applicable. Responsible for audit function(s) and take appropriate action(s) to assure compliance. Working in partnership with Development and Manufacturing (as well as other functions) to design processes and procedures related to Quality Assurance and Compliance activities that enhance cGMP operations and their continuous improvement. Annual performance assessment of Quality / Compliance staff working within the region. Will Assist department head with all Quality / Compliance matters within the region pertaining to all Regulatory, Customer and / or Vendor Audits. Actively implements best industry practices (i.e., electronic enterprises, etc.).
