Director of Quality (49956)

RAINING ROSE INC•Cedar Rapids, IA

91d•Onsite

About The Position

The Director of Quality leads the organization’s quality function across body care and OTC product lines, ensuring all manufacturing processes and finished goods consistently meet company, customer, and regulatory requirements. This role is accountable for building and sustaining a robust Quality Management System, driving a culture of quality and compliance, and partnering cross-functionally to support safe, effective, and regulatory-ready products.

Requirements

Strong written and verbal communication skills with prevalent professional demeanor.
Ability to mentor, train, motivate, direct, and empower a team.
Strong leadership skills.
High ethical standards.
Excellent planning and organizational skills.
Ability to develop personnel and equipment structures to support present and future operations.
Analytical skills to identify and resolve problems in a timely manner.
Ability to work effectively across departmental teams.
Maintain professional technical knowledge.
Mathematical aptitude.
Proficient in Microsoft Office Suite Products and ability to learn new systems quickly.
Bachelor’s degree in relatable field preferred.
A minimum of 5–7 years of management and/or leadership experience required.
A minimum of 5+ years’ experience in quality assurance or quality management within pharmaceutical, body care, or similarly regulated manufacturing is required.
In-depth knowledge of cGMP regulations (21 CFR Parts 210/211), ISO 22716, OSHA requirements, and pharmaceutical/cosmetic quality standards required.
Knowledge of inspection and quality control methods and equipment.

Nice To Haves

Experience in laboratory testing that includes the use of the following instrumentation: Brookfield, viscometer, penetrometer, FTIR, HPLC, UV/VIS preferred.
Experience with a wide variety of measuring instruments and complicated product development is preferred.
Experience with and knowledge of internal audits.
Experience with quoting projects, product cost analysis, and ROI analysis preferred.
Technical writing experience preferred.
Knowledge of analytical theories required.
Knowledge of material inspection methods and techniques preferred.
Knowledge of metric and dashboard development preferred.
Training and understanding of laboratory hazards preferred.
Experience supporting or leading FDA inspections, regulatory audits, or third-party certification audits preferred.
Experience managing CAPA systems, deviation investigations, and out-of-specification (OOS) events in a pharmaceutical or regulated manufacturing environment preferred.

Responsibilities

Develop, implement, and maintain an effective Quality Management System (QMS) covering body care and OTC product manufacturing, ensuring alignment with regulatory frameworks (21 CFR Parts 210/211, ISO 22716, ICH quality guidelines).
Oversee the inspection and testing of raw materials, in-process goods, and finished products to ensure they meet company and regulatory quality standards.
Lead investigations into product quality issues, customer complaints, and non-conformities, and develop corrective and preventive actions.
Manage lab testing, calibration, and maintenance of laboratory equipment.
Supervise QC laboratories, stability programs, microbiological testing, and product validation studies.
Ensure compliance with all applicable regulations governing pharmaceutical manufacturing (21 CFR Parts 210/211) and body care/cosmetic products (FDA, EU Cosmetics Regulation, USDA, ISO 22716, cGMP standards).
Lead efforts to maintain certifications and audit readiness, including FDA inspections, CAPA processes, and third-party certifications.
Lead internal audits and host external regulatory inspections and customer audits.
Stay updated on industry regulations, trends, and new technologies to proactively ensure product quality and safety.
Approve or reject all procedures and specifications impacting the identity, strength, quality, and purity of the drug product.
Manage and mentor the quality team, ensuring high performance, collaboration, and skill development.
Provide leadership in building a culture of quality, safety, and continuous improvement within the manufacturing plant.
Develop training programs and materials to enhance the team's understanding of quality principles and product standards.
Work closely with supply chain to ensure the quality and compliance of raw materials and packaging components, including supplier qualification and approved vendor list management.
Establish and monitor supplier quality metrics and conduct supplier audits and assessments.
Develop and maintain strong relationships with suppliers to resolve quality issues quickly and effectively.
Lead quality improvement projects using tools such as Six Sigma, Lean, or Kaizen.
Drive process optimization initiatives to improve product quality, consistency, and cost-effectiveness.
Drive resolution of nonconformances, deviations, and product quality issues using structured problem-solving methodologies.
Implement and monitor KPIs (Key Performance Indicators) to track the effectiveness of quality management efforts.
Address and resolve customer complaints related to product quality or safety.
Use customer feedback to drive quality improvements and ensure customer satisfaction.
Participate in the product development process, providing input on product formulation, packaging, and production.
Prepare and present reports on quality performance, trends, and improvement initiatives to senior management.
Maintain accurate documentation related to quality processes, audits, investigations, and corrective actions.
Ensure the proper documentation and traceability of all quality-related activities.
Report any product issues relating to quality and product safety to the Chief Operating Officer.
Display and promote company values (ASPIRE: Attitude, Safety, Passion, Integrity, Relationship, and Evolve).
Other duties as assigned.