Supplier Quality Management Supervisor

Job Description

Job Description

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

The Supervisor, Supplier Quality Management is responsible for the daily oversight and execution of the Supplier Quality Management (SQM) Program to ensure suppliers, materials, and service providers meet applicable quality and regulatory requirements.

This role provides direct leadership to Supplier Quality personnel and supports supplier qualification, supplier performance monitoring, material review activities, supplier investigations, and risk-based supplier lifecycle management.

The Supervisor partners cross-functionally with Quality Assurance, Supply Chain (Procurement, Planning, and Warehousing), Manufacturing, and external suppliers to support reliable material supply, regulatory compliance, and continuous improvement initiatives across the site.

This position is responsible for driving operational execution of supplier quality activities, monitoring key performance indicators, supporting supplier remediation initiatives, and ensuring adherence to internal procedures and global quality standards.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

• Supervises daily Supplier Quality Management (SQM) operations including workload coordination, prioritization, escalation management, and execution of supplier quality activities
• Provides direct leadership, coaching, mentoring, and development to Supplier Quality personnel, including support of onboarding, training, and qualification activities
• Oversees supplier qualification, requalification, and supplier lifecycle management activities in accordance with site procedures, regulatory expectations, and risk-based principles
• Supports management and maintenance of the Approved Supplier List (ASL), including supplier approval status, periodic reviews, and supplier performance monitoring activities
• Performs and/or approves supplier qualification assessments utilizing supplier questionnaires, quality agreements, audits, technical documentation, risk assessments, and supplier performance data
• Supports the establishment and adherence to the supplier audit schedule. In execution and tracking of supplier audits, including audit scheduling, audit response coordination, effectiveness follow-up, and supplier remediation activities
• Responsible for identifying and prioritizing supplier audits including requirements for and performance of supplier audits; and issuance of reports and coordination of responses
• Collaborates cross-functionally with Supply Chain, Manufacturing, Warehouse, QC, Process Engineering, and Project Management to support compliant and reliable material supply
• Responsible for establishing, maintaining, and evaluation of compliance to Quality Agreements with Material Suppliers and Service Providers
• Responsible for partnering with customers across site, key stakeholders, and management, to communicate/escalate and ensure timely and adequate management of quality risks
• Monitors supplier quality metrics and key performance indicators (KPIs) to identify trends, risks, and opportunities for continuous improvement and site QMRs
• Provides oversight and support for supplier-related investigations, supplier corrective actions (SCARs), material review board (MRB) activities, deviations, complaints, and discrepancy investigations
• Supports supplier change management activities, including assessment of supplier-initiated changes and evaluation of potential quality, regulatory, and operational impacts
• Supports inspection and audit readiness activities related to supplier quality systems, supplier oversight, and material qualification processes
• Assists with development, implementation, and continuous improvement of supplier quality procedures, processes, templates, and training materials
• Escalates significant supplier quality risks, compliance concerns, or supply continuity issues to Quality Management, as appropriate
• Partners with internal stakeholders and external suppliers to support effective communication, issue resolution, and continuous improvement initiatives
• Supports maintenance of supplier quality records, quality systems, and electronic documentation systems in accordance with applicable procedures and data integrity expectations
• Participates in departmental initiatives, quality improvement activities, and site compliance programs to support overall business and quality objectives

LEADERSHIP & BUDGET RESPONSIBILITIES

Manages daily activities of Supplier Quality personnel including assignment coordination, workload balancing, prioritization, and escalation management to support departmental and site objectives. Carries out lead responsibilities in accordance with the organization's policies and applicable laws.

Provides leadership, coaching, mentoring, and technical guidance to Supplier Quality staff to support employee development, training progression, and execution of supplier quality responsibilities. Supports onboarding and training of new employees, including development and maintenance of training materials, procedures, templates, and work practices related to Supplier Quality Management activities.

Monitors team performance and operational metrics to support timely execution of supplier qualification, supplier audit, and material support activities. Collaborates with Quality Management to support resource planning, prioritization of departmental initiatives, and continuous improvement activities within the Supplier Quality Management Program.

Promotes a culture of quality, compliance, accountability, collaboration, and continuous improvement consistent with company values and regulatory expectations.

Assists in management of departmental expenses and resource utilization to support budgetary objectives and efficient execution of Supplier Quality activities.

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

Bachelor's Degree (BS) with 6 years of related experience and/or training; or equivalent combination of education and experience, including experience in a Manufacturing Environment. Previous experience leading teams or coordinating supplier quality activities. Experience with external Quality Auditing is preferred. Should have a background working with SAP (or similar ERP System), TrackWise, MasterControl, and Microsoft Office Suite.

LANGUAGE SKILLS

Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.

MATHEMATICAL SKILLSAbility to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume.
REASONING ABILITY

Ability to solve practical problems and deal with a variety of concrete variables in

situations where only limited standardization exists. Ability to interpret a variety of

instructions furnished in written, oral, diagram, or schedule form.

CERTIFICATES, LICENSES, REGISTRATIONS

ASQ Certified Quality Auditor (CQA), Certified Pharmaceutical GMP Professional (CPGP), Certified Supplier Quality Professional (CSQP), or equivalent quality-related certification(s) are preferred, but not required.

Professional certifications related to Quality Assurance, Supplier Quality Management, auditing, or pharmaceutical compliance are considered beneficial for this position.

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 and work with hands. The employee frequently is required to talk or hear. The employee is occasionally required to stand and walk. The employee may

occasionally lift and/or move up to 25 pounds.

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. The employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, and low levels of toxic or caustic chemicals. 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.

• Relevant experience in pharmaceutical/biopharmaceutical/chemical/ manufacturing processes and related Quality Assurance, Quality Auditing and Supplier Management
• Strong working knowledge of cGMP, GLP, good clinical practices, FDA Guidelines and Points to Consider documents, and standards routinely used in the industry (ANSI, ISO, Federal Standards)
• Strong analytical, organizational and scheduling skills, and creative problem-solving skills
• Ability to prioritize multiple competing operational activities in a fast-paced manufacturing environment
• Strong investigation, risk assessment, and problem-solving skills
• High level of interpersonal skills with strong negotiation skills and contract development experience
• Ability to communicate effectively across operational, technical, and leadership levels
• Experience working within cross-functional quality systems and supplier oversight programs
• Proficient in computer systems such as word processing, spreadsheets, and ERP software packages (SAP)
• Strong written and verbal communication, and presentation skills
• High degree of business ethics

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 August 21, 2026