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Associate Dir., Quality Systems and Compliance
JOB_REQUIREMENTS
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CordenPharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical, and biotech companies manufacture medicines with the ultimate goal of improving people’s lives.
Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being.
Our People Vision
We strive for excellence. We share our passion. Together, we make a difference in patients' lives.
SUMMARY
This role will have responsibility for Quality Systems and Compliance Management including Deviation, CAPA, and Change Control Quality oversight, Master Control oversight, Supplier Quality Management (SQM), Document Control and Document Management, Regulatory Inspections and Client Audit oversight, and Quality Metrics. The Associate Director of Quality Systems and Compliance will lead monthly Quality Management Review (QMR) and will drive Quality and Site Metrics for the Colorado Corden site.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Include the following. Other duties may be assigned.
- Oversight of Deviations (Quality Systems)
- Oversight of CAPAs (Quality Systems)
- Oversight of the Change Control Program
- Oversight of Master Control
- Oversight of Regulatory Inspections and Client Audits (oversee Quality Compliance Manager)
- Oversee Document Control and Document Management
- Oversee Supplier Quality Management (SQM)
- Organize and lead monthly Quality Management Review (QMR)
- Drive compliance and gap assessments for Corporate Standards
- Drive and provide regular metrics updates to the Leadership Team and site
- Participate in Global Corden Quality Systems discussions
- Exceptional Management Skills
- Exceptional Communication Skills (both written and verbal)
- Strong Quality and Regulatory knowledge
- Ability to transform and drive improvement to systems and organizations
LEADERSHIP & BUDGET RESPONSIBILITIES
Provide strong leadership to the organization and be able to collaborate well cross-functionally. Provides guidance, and partners with the Head of QA and QC to stay within budget and determine budget requirements year over year.
SAFETY & ENVIRONMENTAL RESPONSIBILITIES
Every individual is personally responsible for the safety and environmental aspects of their 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
BA or BS (scientific degree preferred) from a four-year university ; and 15 years of related experience; or equivalent combination of education and experience. Strong Quality background and experience is a must
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 the 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.
- Leadership and deep knowledge of the concepts (above described as responsibilities)
- 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
- Good 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 Parental Leave
- Tuition Reimbursement
- Wellness Program
- Vacation – Three Weeks 1st Year
- Vision Insurance
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.
This post will expire November 24, 2025
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