Senior Manager of Quality (ARG) chez Careers with WM Partners' Portfolio Companies

Description

ABOUT ALLERGY RESEARCH GROUP 

For 45 years, Allergy Research Group® has been a leading innovator and educator in the natural products industry, and is known for clean, high-quality, hypoallergenic supplements. We’re on a mission to partner with Healthcare Practitioners around the world, who are passionate about integrative medicine, and empower them with the tools necessary to help their patients achieve the confidence that comes from great health! Learn more at AllergyResearchGroup.com. 

ABOUT THE ROLE 

At ARG, quality is paramount. The Senior Manager of Quality is responsible for leading the day-to-day Quality Control, Quality Assurance, and Quality Operations functions at ARG. This role ensures ARG products conform to company quality standards, and cGMP requirements. 

You will be a leader, guide the design and implementation of quality systems, train personnel, work with product development to ensure new products have quality built in, know GMPs and ensure manufacturing partners follow relevant cGMP standards, ensure products meet labeling requirements, release products for sale, conduct investigations of issues and write up corrective and preventative actions, ensure facility registrations and certifications are up to date for manufacturing partners, .  

This position reports to the Director of Medical Affairs and is responsible for executing the company’s quality strategy while driving continuous improvement initiatives. 

WHAT YOU WILL DO 

•  Leads execution of quality priorities, processes, and procedures, including oversight of SOP development and maintenance. 

• Ensures the company operates in compliance with applicable legal regulations and cGMP requirements, including 21 CFR 111. 

• Manages and develops the Quality team, including task prioritization, training, performance reviews, and personnel development. 

• Ensures consistent quality standards across multiple contract manufacturers and contract laboratories. 

• Prepares and manages Quality Agreements with third parties responsible for cGMP manufacturing, testing, or distribution of products. 

• Manages product complaints to resolution and ensures proper corrective and preventive actions are implemented, documented, and closed appropriately. 

• Leads cross-functional process improvements and continuous improvement initiatives for Quality operations. 

• Promotes a culture of compliance and ethical behavior within the company. 

• Works with manufacturing partners to support operational excellence and continuous improvement. 

•  Exercises decision-making authority for quality matters within scope of role and escalates significant compliance risks as appropriate. 

• Initiates and manages investigations for non-conforming materials and finished goods. 

• Oversees the deviation and CAPA program to ensure thorough investigations, product impact assessments, root cause analysis, and corrective actions. 

• Reviews Change Controls to ensure they are justified and meet cGMP requirements. 

• Oversees the training program to ensure employees comply with SOPs and GMP requirements. 

• Oversees the stability program to ensure products meet regulatory requirements for labeling claims. 

• Supports new product development, reformulation, and packaging configuration to meet regulatory requirements. 

• Leads quality-related process improvements. 

•  Manages departmental budget in alignment with approved financial plans. 

• Directly interfaces with Customer Care, Sales, and Customers and serves as point of contact for product or raw material quality inquiries and responds to technical quality concerns. 

• Performs other duties as assigned. 

Requirements

WHAT YOU BRING 

• Bachelor of Science degree  

• 5+ years experience managing pharmaceutical or dietary supplement quality departments. 

• 2+ years in a leadership role 

• Strong experience and passion for preventative procedures to ensure consistent quality. 

• Computer proficiency required 

• Solutions oriented and pragmatic. 

• High ethical level; principle-centric with pragmatic implementation 

• A team player able to work collaboratively and successfully across functions 

• Exceptional interpersonal and relationship building skills 

• Experience in communicating effectively 

• Attentive to detail 

• Ability to undertake situations with a proactive and “hands-on” approach 

• Commitment to lifelong learning and willingness to continuously upgrade skill set to excel at the requirements of the position 

• Agile in the use of office software, systems, and communication platform 

Benefits

PERKS & BENEFITS 

ARG offers a comprehensive benefit package which includes company-paid health benefits, disability and life insurance, generous paid time off, 401(k) match, parental leave, product discounts and more! 

The annual base salary range for this position is $125,00 - $140,000 USD/year. The actual annual base salary offered may be adjusted based on a variety of factors, including but not limited to: location, education, skills, training, and experience. This position may also be eligible for an annual discretionary bonus.   

Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, disability status, age, sexual orientation, gender identity and expression, marital status, or any other legally protected factor. ARG is committed to offering reasonable accommodation to job applicants with disabilities. ARG does not accept unsolicited agency resumes and is not responsible for any agency fees related to unsolicited resumes.