Hybrid Senior Manager of Quality – ARG

Posted 50 minutes ago

Apply now

About the role

  • Senior Manager of Quality responsible for quality control and assurance processes at Allergy Research Group. Ensuring compliance and leading continuous improvement initiatives for high-quality products.

Responsibilities

  • 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

  • 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

  • company-paid health benefits
  • disability and life insurance
  • generous paid time off
  • 401(k) match
  • parental leave
  • product discounts

Job title

Senior Manager of Quality – ARG

Job type

Experience level

Senior

Salary

$125,000 - $140,000 per year

Degree requirement

Bachelor's Degree

Location requirements

Report this job

See something inaccurate? Let us know and we'll update the listing.

Report job