Director, Quality Control
Apply NowCompany: Corden Pharma Boulder, Inc.
Location: Boulder, CO 80302
Description:
EQUAL OPPORTUNITY EMPLOYER
Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices.
CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2,600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people's lives.
Our network in Europe and the U.S. offers flexible and specialized solutions across six technology platforms: Peptides, Lipids, & Carbohydrates; Injectables; Highly Potent & Oncology; Oligonucleotides and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.
SUMMARY
Responsible for the Site Quality Control (QC) Department, including Quality Control, In-Process Testing (IPC), Microbiology, and Stability. The QC Director is responsible for leading, developing, and engaging the Site QC Team to ensure successful customer project delivery. Provides leadership for QC in accordance with directions from the Head of QA and QC based on the organization's policies, applicable laws, and guidance. Quality Control activities to include the direction of all related operations pertaining to Quality Control (QC), IPC, Microbiology, and Stability. The QC Director is responsible for ensuring that adequate resources are retained, trained, qualified, validated, and deployed timely to ensure compliant material is tested per site schedules. Ensures cGMP throughout the product life cycle is maintained and compliant with company quality and compliance policies, and practices based on applicable regulation and guidance.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Include the following. Other duties may be assigned.
LEADERSHIP & BUDGET RESPONSIBILITIES
Provides guidance and leadership for the department. Contributes to the direction and oversight of the operational aspects of Corden Pharma Colorado by advising the site Operating Committee. Accountable for operational budget and financial performance of the Quality Control Organization.
SAFETY & ENVIRONMENTAL RESPONSIBILITIES
Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.
QUALITY RESPONSIBILITIES
Corden Pharma Colorado (CPC) is a manufacturer of a variety of pharmaceutical products. In following Current Good Manufacturing Practices (cGMP), Corden Pharma Colorado manufactures in accordance with the US Food and Drug Administration (FDA), International Council for Harmonisation Q7 (ICH), and other global regulations as applicable. This is critical as it is our mission to not place patients at risk due to inadequate safety, quality, or efficacy. CPC's Quality Management System, which incorporates cGMP, is designed to deliver this quality objective. Attainment is produced through the requisite participation and commitment of all staff across departments and at all levels within the company.
cGMP is the part of Quality Management System ensuring products are consistently produced to accurate quality standards. Adherence to clearly defined procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Bachelor's Degree from college or university; and 20 years of related experience; or equivalent combination of education and experience.
LANGUAGE SKILLS
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.
MATHEMATICAL SKILLS
Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
REASONING ABILITY
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent, and to draw and interpret bar graphs.
CERTIFICATES, LICENSES, REGISTRATIONS
None.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit; work with hands; and talk or hear. The employee is occasionally required to stand; walk; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include ability to adjust focus.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, and noise typical of an office environment.
CORE COMPETENCIES
These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.
SALARY
Actual pay will be based on your skills and experience.
BENEFITS
This post will expire on 5/3/2025
Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices.
CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2,600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people's lives.
Our network in Europe and the U.S. offers flexible and specialized solutions across six technology platforms: Peptides, Lipids, & Carbohydrates; Injectables; Highly Potent & Oncology; Oligonucleotides and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.
SUMMARY
Responsible for the Site Quality Control (QC) Department, including Quality Control, In-Process Testing (IPC), Microbiology, and Stability. The QC Director is responsible for leading, developing, and engaging the Site QC Team to ensure successful customer project delivery. Provides leadership for QC in accordance with directions from the Head of QA and QC based on the organization's policies, applicable laws, and guidance. Quality Control activities to include the direction of all related operations pertaining to Quality Control (QC), IPC, Microbiology, and Stability. The QC Director is responsible for ensuring that adequate resources are retained, trained, qualified, validated, and deployed timely to ensure compliant material is tested per site schedules. Ensures cGMP throughout the product life cycle is maintained and compliant with company quality and compliance policies, and practices based on applicable regulation and guidance.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Include the following. Other duties may be assigned.
- Goal alignment with the Head of QA and QC. Goal realization includes achievement consistent with site strategy, and developing employees; planning, assigning, and managing work; and continuous improvement, addressing complaints and resolving problems
- Participates directly in customer and government quality audits and inquiries from a QC perspective
- Oversees all departments within Quality Control including QC, IPC, Microbiology, and Stability
- Works closely with Operations, Warehouse/Supply Chain, Analytical Development, Program Management, and Quality to ensure timelines are understood and met to support disposition
- Develops strong relationships with Clients
- Supports Client Audits and Regulatory Inspections as the responsible party for all items that pertain to QC, IPC, Microbiology, and Stability
- Ensures safety is a key priority for all operations within the QC, IPC, Microbiology, and Stability Labs
- Implements and maintains Operational Excellence (OE) practices including 5S
- Responsible for oversite of 24/7 (four shifts) of QC Analysts that support Operations
LEADERSHIP & BUDGET RESPONSIBILITIES
Provides guidance and leadership for the department. Contributes to the direction and oversight of the operational aspects of Corden Pharma Colorado by advising the site Operating Committee. Accountable for operational budget and financial performance of the Quality Control Organization.
SAFETY & ENVIRONMENTAL RESPONSIBILITIES
Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.
QUALITY RESPONSIBILITIES
Corden Pharma Colorado (CPC) is a manufacturer of a variety of pharmaceutical products. In following Current Good Manufacturing Practices (cGMP), Corden Pharma Colorado manufactures in accordance with the US Food and Drug Administration (FDA), International Council for Harmonisation Q7 (ICH), and other global regulations as applicable. This is critical as it is our mission to not place patients at risk due to inadequate safety, quality, or efficacy. CPC's Quality Management System, which incorporates cGMP, is designed to deliver this quality objective. Attainment is produced through the requisite participation and commitment of all staff across departments and at all levels within the company.
cGMP is the part of Quality Management System ensuring products are consistently produced to accurate quality standards. Adherence to clearly defined procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Bachelor's Degree from college or university; and 20 years of related experience; or equivalent combination of education and experience.
LANGUAGE SKILLS
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.
MATHEMATICAL SKILLS
Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
REASONING ABILITY
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent, and to draw and interpret bar graphs.
CERTIFICATES, LICENSES, REGISTRATIONS
None.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit; work with hands; and talk or hear. The employee is occasionally required to stand; walk; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include ability to adjust focus.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, and noise typical of an office environment.
CORE COMPETENCIES
These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.
- Deep knowledge of regulatory requirements associated with QC, IPC, Microbiology, and Stability
- Deep understanding of contamination control/microbiological control strategies. Knowledge of Annex 1 requirements is highly desirable
- Deep understanding of multiple methods/assays related to testing of Active Pharmaceutical Ingredients (API)
- Deep understanding of an effective stability program
- Deep understanding of microbiological programs including environmental monitoring, gowning, disinfectant efficacy studies, water monitoring, equipment cleaning (related to microbiological programs), and qualification of rooms to meet the requirements of Grade C and D classified space
- Multiple years of experience representing QC Programs during Regulatory Inspections
- Governance and decision making regarding regulatory compliance and operational knowledge of API manufacture
- Effective in prioritizing workloads, resolution of issues based on compliance, and scientifically documented risk
- Excellent customer service skills
- Business acumen to drive successful customer experience while meeting business targets from a Quality perspective
- Excellent written and oral communication skills
- Computer skills with intermediate ability to use Microsoft Office Suite
- Strong planning, implementation, and follow-up skills
- Good facilitation skills and ability to interact with colleagues from all levels of the organization
- High analytical capabilities
SALARY
Actual pay will be based on your skills and experience.
BENEFITS
- 401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
- Accident Plan
- Critical Illness Insurance
- Dental Insurance
- Disability Insurance
- Employee Assistance Program
- Flexible Spending Account
- Health Insurance PPO/HSA
- Hospital Indemnity Plan
- ID Theft Protection
- Life Insurance
- Paid Maternity/Paternity Leave
- Tuition Reimbursement
- Wellness Program
- Vacation - Three Weeks 1st Year
- Vision Insurance
This post will expire on 5/3/2025