Sr. QA Systems Audit & Regulatory Specialist

Corden Pharma Colorado

About The Position

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.

Requirements

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
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
Direct experience with regulatory inspections, client audits, and internal auditing required
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.
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
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.

Nice To Haves

Experience with NDA/BLA submissions and eCTD submission formats, preferred
ASQ Certified Quality Auditor (CQA) Certification, preferred.
Working knowledge of eQMS Systems required (Master Control or TrackWise preferred)
ASQ CQA certification, preferred

Responsibilities

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)

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