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Sr. QA Systems Audit & Regulatory Specialist

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

Administers Quality System Programs, procedures, and controls, ensuring that performance and quality of products conform to established Corden standards and federal regulations. Works directly with all departments to administer the Internal and External Audit Program. Participates in scheduling, hosting, and responding to client audits and regulatory inspections. Participates in scheduling and performing internal audits. Develops GMP training relevant to audit programs and regulatory areas of focus.

Drives compliance to regulatory policies consistent with U.S. and International laws and regulations. Plans, coordinates, and issues regulatory documents on behalf of U.S. and International agencies. Interacts with Regulatory agencies during audits and during the drug filing process.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

Manages the implementation and maintenance of the Internal and External Audit Program for all sites
Works directly with clients to schedule audits, host audits, and respond to client reports
Works directly with all departments to schedule internal audits, perform the internal audits, complete the reports, and develop appropriate CAPAs
Hosts and participates in regulatory inspections, including coordination of audit responses and CAPA development and tracking
Develops and administers GMP training relevant to audit programs and regulatory areas of focus for all impacted employees
Prepares, reviews, and maintains regulatory documents, and GMP certificates and licenses in relation to API manufacturing site compliance and in support of customer requests
Develops, implements, and maintains regulatory strategies for successful, timely filings (BLA, NDA) to health authorities
May be responsible for planning, authoring, and/or reviewing NDA or BLA dossiers at client requests
May prepare or support preparation of NDA or BLA dossiers for customers
Maintains the Site Master File
Drafts and updates regulatory sections related to manufacturing processes, controls, analytical methods, stability, and quality systems, as requested by the customer
Tracks regulatory commitments and correspondence to ensure timely responses and updates
Develops, reviews, and approves procedures related to the systems
QA Systems regulatory resource on Quality Records (CAPAs, Change Control, Deviations)

LEADERSHIP & BUDGET RESPONSIBILITIES

Provides guidance and leadership where appropriate based upon the results of the system administration process. Responsible for participating in the budget process for input as required.

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.

Knowledge of cGMPs and Corden Quality SOPs as they apply to Quality Systems and audit activities
Knowledge of Quality System audit practices
Knowledge of GMP training

EDUCATION and/or EXPERIENCE

Bachelor’s or advanced Degree (MS, PhD, PharmD) in Biology, Chemistry, or related life science and 10 years of Quality Assurance, Regulatory and/or Auditing experience within the Pharmaceutical Industry; or an equivalent combination of education and industry experience.

Experience with Regulatory Submissions required
Experience with NDA/BLA submissions and eCTD submission formats, preferred
Direct experience with regulatory inspections, client audits, and internal auditing required

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 procedures. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Ability to speak, read and write in English.

MATHEMATICAL SKILLS

Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

REASONING ABILITY

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

CERTIFICATES, LICENSES, REGISTRATIONS

ASQ Certified Quality Auditor (CQA) Certification, preferred.

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 talk or hear. The employee frequently is required to stand, walk, and sit. The employee is occasionally required to work with hands; 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 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and 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 wet and/or humid conditions, moving mechanical parts, and outside weather conditions. The noise level in the work environment is usually moderate.

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.

Ability to apply attention to detail, regulatory requirements, and a practical, defendable, logical approach to problem solving
Working knowledge of eQMS Systems required (Master Control or TrackWise preferred)
Direct experience performing audits (internal, supplier, regulatory, etc.)
ASQ CQA certification, preferred
Strong understanding of global regulatory regulations for APIs and GMP manufacturing
Able to analyze regulatory requirements (both U.S., European, and ROW) and translate requirements to strategies that can be articulated and implemented within the business
Exceptional technical writing skills with the ability to synthesize complex data into clear regulatory language
Demonstrated ability to collaborate and communicate across all levels of the organization, as well as with customers and regulators
Knowledge of current Good Manufacturing Practices, ICH Guidelines, internal procedures, and other pertinent national and international regulations
Excellent verbal, writing, interpretive, presentation, and interpersonal skills

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 April 17, 2026

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