Director Of Quality Assurance

Company Overview

For more than 40 years, Federal Package® has been the preferred contract manufacturer for many of the leading personal care companies. Due to our extensive capabilities and dedication to quality products and services, Federal Package has become the go-to source for companies in the health, beauty and personal care industries searching for all aspects of contract manufacturing including research and development; formulation; blending and filling; decorating and labeling; and health and beauty containers. We offer competitive wages, a lucrative bonus structure, comprehensive benefits package, 401K, and many other additional perks.

Job Summary
The Quality Director will perform in a leadership and hands on engineer capacity, responsible to lead company quality initiatives, lead the quality team and direct judgments of Quality specifics based on experience with processes, capabilities, industry standards and customer expectations. Customer facing position to manage audits, address and resolve complaints.

Key Responsibilities

• Manage the quality strategy and systems for all operational processes. Coordinate with internal teams to create new documents, revise existing documents, determine training needs, oversee the approval and distribution processes, maintain document control process (database) and coordinate document reviews. Manage and review, storage and archiving of Quality records. Fulfill requests for data and reports (ex. Corporate, Environmental).
• Lead NCMR, CAPA, deviation and improvements in Quality area and provide training and guidance to QA team members for routine QA rounds, improvements in GMP, SOPs, Forms, Validation
• Lead and coordinate other Safety / Quality program efforts such as Customer Audits, certification audits, facility verification / validation activities, improvements, etc.
• Develop quality plans for new product introductions, test methods and process inspections, including writing procedures for selecting and applying correct measuring and analytical tools.
• Ensure a high level of internal and external customer service, interfacing with customers to resolve quality concerns and vendors to ensure quality of all purchased parts.
• Lead investigations of in-plant quality incidents (foreign material, nonconforming product) and consumer complaints, identifying root causes and facilitating corrective action with plant teams. Interprets and reports consumer complaint data trends and facilitates action plans.
• Manage Supplier Quality Management Program including monitoring of supplier performance, conduct audits and trend analyses.
• Lead plant internal quality inspections. Create and coordinate schedule, training, qualification and calibration of auditors, develop checklists, generate reports and follow-through with corrective action assignees to ensure CARs are completed, effectiveness is verified, and audits are closed. Participate in programs as an auditor/inspector.
• Conducts audits and assessments to champion plant traceability systems and mock recall exercises for ingredients, packaging, and finished product. Executes plant-scheduled and corporate-initiated trace exercises.
• Supervise workers engaged in inspection and testing activities to ensure high productivity and high technical integrity.
• Identify opportunities and design plans for expanded use of the plant electronic data collection system, anticipating future applications.
• Responsible for US regulatory submissions, including FDA drug and establishment registrations, supplement notifications, WERCS and EPA and state pesticide registrations
• Create product quality documentation system by writing and updating Quality Assurance procedures.
• Hire and retain quality staff by recruiting, selecting, orienting, and training employees.
• Manage quality staff job results by coaching, counseling, and disciplining employees.
• Collaborate with other members of management to develop new products and engineering designs and manufacturing and training methods.

Minimum Qualifications

• Bachelor’s degree in Engineering, Chemistry or similar
• 5-8 years of Quality Management/Regulatory Affairs experience in a manufacturing environment and regulated industry, preferably skin and personal care products including OTC
• Experience managing Quality Issue Alerts
• Experience managing customer audits

Preferred Qualifications

• Skin and personal care including OTC claim review experience strongly preferred
• Proficient navigating 21 CFR, FTC, EU Regulations (EFSA and ECHA), Prop 65 Listing, and EPA Pesticides Inerts List
• Certification in Quality (ASQ), Engineering (PE), ISO

Knowledge, Skills and Abilities

• Track record adhering to compliance requirements (i.e. FDA, Health Canada, EPA, FTC, cGMP, ISO, etc.)
• Professional approach to address and resolve customer complaints
• Oversee Issue Alert (IA) process
• Lean manufacturing and continuous improvement
• Strong leadership skills
• Experience motivating and leading teams
• Excellent problem solving and critical thinking ability
• Confident independent decision making
• Strong attention to detail
• Strong organization, prioritization, multi-tasking and planning skills
• Strong interpersonal and communication skills, verbal and written
• Flexibility to adapt and meet fluctuating schedule and priority changes