What are the responsibilities and job description for the Director, QC Labs position at Endo?
Why Endo?
We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
Job Description Summary
The US Quality Control Chem Lead is a national level job responsible for the QC Chem operations in multiple plants around the US. Responsible and accountable for directing and managing the compliant, effective, and efficient operation of all US ENDO manufacturing site laboratories and the contract laboratories directly contracted by the organization. The US Quality Control Chemistry Lead is expected to exemplify and lead with ENDO Values and is accountable for the operation of the US QC Chemistry team operating in-line with the values to foster a Culture of Quality, Compliance and Excellence.
Job Description
The US Quality Control Director is a national-level role, responsible for overseeing quality control (QC)
operations across multiple manufacturing plants throughout the United States. This position involves directing
and managing the compliant, effective, and efficient functioning of all US ENDO manufacturing site
laboratories, as well as the contract laboratories directly engaged by the organization.
Key Responsibilities Include:
Leadership and Management: Providing strategic direction and oversight to ensure all QC operations
meet regulatory and company standards.
Compliance and Efficiency: Ensuring that all laboratory activities are conducted in compliance with
relevant regulations and standards, while also optimizing processes for maximum efficiency.
Quality Assurance: Upholding the highest standards of quality in all QC activities, fostering a culture of
continuous improvement.
Contract Management: Overseeing the performance and compliance of contract laboratories to
ensure they meet the organization’s quality standards.
The US Quality Control Director is expected to exemplify and lead with ENDO Values, which include integrity,
accountability, and excellence. This role is crucial in ensuring that the US QC team operates in alignment with
these values, fostering a culture of Quality, Compliance, and Excellence across all operations.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend
authority (capital, operating, etc.), P&L responsibility, etc.
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
Accountability Responsibilities % of Time
Page 2 of 3
Endo Job Description Template - Revised February 2022
Quality and
Compliance
Assesses US QC Chemical and Microbial operations from a
strategic perspective to ensure that products consistently meet
quality, integrity, functionality, and all other specified
requirements.
Ensures staff are thoroughly trained in all GxP manufacturing
operations and documentation, while strictly adhering to safety
guidelines. Builds effective teams by leveraging diverse skills
and perspectives to achieve common goals.
Prepares QC site managers for audits and inspections and
actively participates in these processes.
Directs and guarantees the accurate preparation of documents
for laboratory investigations, out-of-specifications, deviations,
and CAPAs. Additionally, directs the interpretation and
presentation of data, conducts statistical analysis, and monitors
trends.
Strategic Planning
Develops and implements long-term strategies for quality
control to align with the business expectations and goals
Delivery and
Performance
Directs and participates during initial and subsequent transfer
of procedures and analytical methods to support GxP
manufacturing campaigns.
Facilitates communication across sites including key
stakeholders in Ops, QA, and plant management.
Collaborates with management and senior staff across
production departments, QA, and other key stakeholders to
develop and establish robust QC Chem standards of operations.
Finance
Manages the budget for QC operations, ensuring cost-effective
use of resources and operation within business expectations
Leadership/Culture
Directs and oversees all managerial staff for QC US operations,
creating competent leaders and employees that embody
ENDO’s values
Leads and mentors local QC managers in the execution of QC
tests, effective people management, and developing strong
relationships and collaboration.
Fosters a culture of Speaking Up.
Seeks to embody ENDO’s values, promoting a positive and
productive work environment
Evaluates existing challenges and recommends ongoing
improvements to enhance compliance and drive innovation
within US QC operations.
Coaches and mentors QC team.
Ensures continuous training and professional development for
the QC team to keep up with industry standards and
technological advancements.
Sets performance metrics and regularly reviews the Quality
Control team’s performance to ensure objectives are met in a
timely and constructive manner
Page 3 of 3
Endo Job Description Template - Revised February 2022
Handles discipline and termination of employees in accordance
with company policy.
Other duties as assigned
Total 100%
Qualifications
Education &
Experience
Minimal acceptable level of education, work experience, and certifications required for the job
Bachelor’s degree in scientific or engineering fields required; Master’s degree
preferred.
Eight to 10 years of related experience required with at least five years as a quality
engineer or similar role highly preferred.
Knowledge
Proficiency in a body of information required for the job e.g., knowledge of FDA regulations,
GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
Strong expertise in generating internal and external documents such as protocols,
summary reports, and SOPs.
Thorough understanding of Quality Control standards and methodologies.
In depth expertise in laboratory related regulations e.g. cGMP, CGLP, Data Integrity
(including IT systems), Risk Management
Thorough understanding of manufacturing and production in the pharmaceutical
industry.
Skills
&
Abilities
Often referred to as “competencies”, leadership attributes, skills, abilities, or behaviors that may be
enterprise, functional or job specific e.g., coaching, negotiation, calibration, technical writing etc.
Outstanding verbal and written communication skills with the ability to train staff,
negotiate and navigate highly political and stressful situations.
Excellent organizational skills and attention to detail.
Strong ability to coach and mentor team members.
Strong analytical and problem-solving skills.
Strong supervisory and leadership skills.
Physical
Requirements
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel
(% of time), driving as part of work responsibilities, etc.
Prolonged periods sitting at a desk and working on a computer.
Must be able to lift up to 15 pounds at times.
Must be able to spend time in laboratory environment as required.
Travel up to 25% may be required.
EEO Statement:
At Endo, we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.
We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
Job Description Summary
The US Quality Control Chem Lead is a national level job responsible for the QC Chem operations in multiple plants around the US. Responsible and accountable for directing and managing the compliant, effective, and efficient operation of all US ENDO manufacturing site laboratories and the contract laboratories directly contracted by the organization. The US Quality Control Chemistry Lead is expected to exemplify and lead with ENDO Values and is accountable for the operation of the US QC Chemistry team operating in-line with the values to foster a Culture of Quality, Compliance and Excellence.
Job Description
The US Quality Control Director is a national-level role, responsible for overseeing quality control (QC)
operations across multiple manufacturing plants throughout the United States. This position involves directing
and managing the compliant, effective, and efficient functioning of all US ENDO manufacturing site
laboratories, as well as the contract laboratories directly engaged by the organization.
Key Responsibilities Include:
Leadership and Management: Providing strategic direction and oversight to ensure all QC operations
meet regulatory and company standards.
Compliance and Efficiency: Ensuring that all laboratory activities are conducted in compliance with
relevant regulations and standards, while also optimizing processes for maximum efficiency.
Quality Assurance: Upholding the highest standards of quality in all QC activities, fostering a culture of
continuous improvement.
Contract Management: Overseeing the performance and compliance of contract laboratories to
ensure they meet the organization’s quality standards.
The US Quality Control Director is expected to exemplify and lead with ENDO Values, which include integrity,
accountability, and excellence. This role is crucial in ensuring that the US QC team operates in alignment with
these values, fostering a culture of Quality, Compliance, and Excellence across all operations.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend
authority (capital, operating, etc.), P&L responsibility, etc.
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
Accountability Responsibilities % of Time
Page 2 of 3
Endo Job Description Template - Revised February 2022
Quality and
Compliance
Assesses US QC Chemical and Microbial operations from a
strategic perspective to ensure that products consistently meet
quality, integrity, functionality, and all other specified
requirements.
Ensures staff are thoroughly trained in all GxP manufacturing
operations and documentation, while strictly adhering to safety
guidelines. Builds effective teams by leveraging diverse skills
and perspectives to achieve common goals.
Prepares QC site managers for audits and inspections and
actively participates in these processes.
Directs and guarantees the accurate preparation of documents
for laboratory investigations, out-of-specifications, deviations,
and CAPAs. Additionally, directs the interpretation and
presentation of data, conducts statistical analysis, and monitors
trends.
Strategic Planning
Develops and implements long-term strategies for quality
control to align with the business expectations and goals
Delivery and
Performance
Directs and participates during initial and subsequent transfer
of procedures and analytical methods to support GxP
manufacturing campaigns.
Facilitates communication across sites including key
stakeholders in Ops, QA, and plant management.
Collaborates with management and senior staff across
production departments, QA, and other key stakeholders to
develop and establish robust QC Chem standards of operations.
Finance
Manages the budget for QC operations, ensuring cost-effective
use of resources and operation within business expectations
Leadership/Culture
Directs and oversees all managerial staff for QC US operations,
creating competent leaders and employees that embody
ENDO’s values
Leads and mentors local QC managers in the execution of QC
tests, effective people management, and developing strong
relationships and collaboration.
Fosters a culture of Speaking Up.
Seeks to embody ENDO’s values, promoting a positive and
productive work environment
Evaluates existing challenges and recommends ongoing
improvements to enhance compliance and drive innovation
within US QC operations.
Coaches and mentors QC team.
Ensures continuous training and professional development for
the QC team to keep up with industry standards and
technological advancements.
Sets performance metrics and regularly reviews the Quality
Control team’s performance to ensure objectives are met in a
timely and constructive manner
Page 3 of 3
Endo Job Description Template - Revised February 2022
Handles discipline and termination of employees in accordance
with company policy.
Other duties as assigned
Total 100%
Qualifications
Education &
Experience
Minimal acceptable level of education, work experience, and certifications required for the job
Bachelor’s degree in scientific or engineering fields required; Master’s degree
preferred.
Eight to 10 years of related experience required with at least five years as a quality
engineer or similar role highly preferred.
Knowledge
Proficiency in a body of information required for the job e.g., knowledge of FDA regulations,
GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
Strong expertise in generating internal and external documents such as protocols,
summary reports, and SOPs.
Thorough understanding of Quality Control standards and methodologies.
In depth expertise in laboratory related regulations e.g. cGMP, CGLP, Data Integrity
(including IT systems), Risk Management
Thorough understanding of manufacturing and production in the pharmaceutical
industry.
Skills
&
Abilities
Often referred to as “competencies”, leadership attributes, skills, abilities, or behaviors that may be
enterprise, functional or job specific e.g., coaching, negotiation, calibration, technical writing etc.
Outstanding verbal and written communication skills with the ability to train staff,
negotiate and navigate highly political and stressful situations.
Excellent organizational skills and attention to detail.
Strong ability to coach and mentor team members.
Strong analytical and problem-solving skills.
Strong supervisory and leadership skills.
Physical
Requirements
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel
(% of time), driving as part of work responsibilities, etc.
Prolonged periods sitting at a desk and working on a computer.
Must be able to lift up to 15 pounds at times.
Must be able to spend time in laboratory environment as required.
Travel up to 25% may be required.
EEO Statement:
At Endo, we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.
