Representative, Quality Unit (QS Manager)

ZEISS•Hebron, KY

9d•Remote

About The Position

The successful candidate will serve as the designated Quality Unit representative with oversight of the Quality Management System (QMS) for a diverse portfolio of regulated products (OTC sterile eyedrops, dietary supplements, cosmetics). As a Label Owner/Distributor, this individual does not manufacture but holds ultimate responsibility for product quality, regulatory compliance, and release. This role also manages the Tier 2 Customer Care function, serving as the escalation point for quality complaints, medical inquiries, and Adverse Event Reporting (AER), working closely with the local Tier 1 Customer Service team.

Requirements

Bachelor’s degree preferred.
Minimum 7-10 years of experience in Quality Assurance or Regulatory Affairs within the Pharmaceutical (OTC) or Dietary Supplement industry.
Experience with Sterile Manufacturing or Quality oversight of sterile products (crucial for eyedrops).
Knowledge of 21 CFR 111 (Dietary Supplements) and 21 CFR 210/211 (Drugs).
Experience handling medical information inquiries, complaint investigations, and submitting Adverse Event reports to regulatory bodies.
Virtual Quality Management: Ability to manage quality remotely through strong vendor relationships and paper-based/digital audits rather than direct floor supervision.
Risk Assessment: Proficient in Risk Management tools (FMEA, HACCP) applied to supply chain and product release.
Communication: Ability to translate complex technical/regulatory concepts into scripts and training for Tier 1 Customer Service agents.

Nice To Haves

Experience with Cosmetic regulations (MoCRA).
Certifications (Highly Desirable): RAC (Regulatory Affairs Certification / Training)
CQA (Certified Quality Auditor by ASQ)
CQM/OE (Certified Manager of Quality/Organizational Excellence)

Responsibilities

Maintain QMS: Develop, implement, and maintain a robust QMS compliant with 21 CFR 210/211 (Drugs), 21 CFR 111 (Supplements), and MoCRA/ISO 22716 (Cosmetics).
SOP Management: Author and approve Standard Operating Procedures (SOPs) regarding document control, change control, deviations, CAPA (Corrective and Preventive Actions), and product recall strategies.
Training: Ensure all employees (including Tier 1 CS staff) are trained on relevant GMPs, GDPs (Good Distribution Practices), and complaint handling procedures.
Contract Manufacturer (CMO) Oversight: Qualify and audit contract manufacturers. Ensure Quality Agreements are in place and enforced.
Sterile Assurance (Eyedrops): specifically review CMO sterility validation data, environmental monitoring summaries, and media fill results before lot release.
Batch Release: Perform final batch record review and release finished goods for distribution, ensuring products meet all specifications (Identity, Purity, Strength, Composition).
Warehousing/Distribution: Oversee temperature-sensitive logistics (cold chain or controlled room temperature) to ensure product integrity during storage and transport.
Label Review: Review and approve product labeling for compliance with FDA "Drug Facts" (OTC), "Supplement Facts" (Dietary Supplements), and cosmetic labeling standards (including MoCRA requirements).
Product Listing: Maintain FDA facility registrations and product listings/drug establishment registrations.
Regulatory Watch: Stay updated on FDA guidance, including the Modernization of Cosmetics Regulation Act (MoCRA) and DSHEA updates.
Escalation Point: Serve as the Tier 2 subject matter expert for the Tier 1 Customer Service team, handling complex product inquiries or medical questions.
Complaint Investigation: Lead investigations into product quality complaints (PQC). Distinguish between non-medical complaints (e.g., broken seal) and Adverse Events (AE).
Adverse Event Reporting (AER): Manage the intake, evaluation, and reporting of Serious Adverse Events (SAEs) to the FDA (via MedWatch/FAERS or CAERS) within mandatory timelines (15-day alerts).
Trend Analysis: Monitor complaint trends to identify potential batch failures or emerging safety signals.