Senior Manager of Quality – ARG
WM Partners, LP
full-time
Posted on:
Location Type: Hybrid
Location: Salt Lake City • Utah • United States
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Salary
💰 $125,000 - $140,000 per year
Job Level
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
SOP developmentcGMP complianceQuality AgreementsCAPA programroot cause analysisChange Controlsproduct complaints managementinvestigations for non-conforming materialsregulatory requirementsquality-related process improvements
Soft Skills
leadershipinterpersonal skillsrelationship buildingcommunicationattention to detailproactive approachteam collaborationethical behaviorsolutions orientedcommitment to lifelong learning
Certifications
Bachelor of Science degree