Quality Manager (Remote)

Quality Manger (Remote)

We are Wholesome Story, a women’s health and fertility supplement company specializing in products that support hormonal balance. We are looking to add a Quality Manager to our rapidly growing team.

Qualifications:

Bachelor's Degree, or equivalent experience, in relevant fields (food science, chemistry, microbiology, pharmacology, etc.)

5-10+ years of direct US dietary supplement/OTC/Consumer Healthcare Quality experience

Knowledge and experience on FDA (and preferably Health Canada) quality standards and applicable laws and regulations, as well as of cGMP standards

Proven Quality advocacy skills with measurable deliverables in the dietary supplement space in US

Experience conducting risk assessments and gap analyses.

Self-motivated with critical attention to detail, deadlines, and reporting Excellent English written and verbal communication skills

Strong analytical, prioritizing, interpersonal, problem-solving, project management (from conception to completion), & planning skills.

Strong verbal and written communication skills (including analysis, interpretation, & reasoning).

Ability to develop and maintain collaborative relationships with peers and colleagues across the organization, as well as internal and external stakeholders.

Ability to work well autonomously and within a team in a fast-paced and deadline-oriented environment

Experience with and/or understanding of scientific analyses relevant to Quality in the supplement industry (CoAs, test specs, FG assays, shelf life, etc.)

Responsibilities:

As Quality Assurance Manager, you will be part of a tight-knit team (with Operations & R&D) responsible for ensuring best practices are followed to create, grow and protect the business.

The Quality Manager is responsible for managing all aspects of quality control, quality assurance, and document control to ensure compliance with local, state, and federal regulations and industry standards (21 CFR 111, UDAF, HACCP, FSMA etc.).

The Quality Manager oversees developing, implementing and maintaining quality programs, policies and procedures.

Manage quality systems to ensure compliance with all applicable regulations and standards from governments and third-party certification agencies.

Manager review and approval of MBRs and MMRs at each step of production process Documentation

Management around non-conformances, CAPA reports, deviations, OOS testing, complaints, etc.

Perform regular internal audits to ensure compliance with SOPs and applicable requirements and regulations

Responsible for ensuring Product Specification and COAs, and other documents are current and updated and cGMP SOPs are reviewed, and revised following revision control procedures.

Manage US GMP compliance within the company with manufacturing partners.

Collaborate across multiple departments to create/manage corporate level procedures and policies that will become part of the centralized technical backbone for Wholesome Story.

Manage and implement Quality Assurance strategies, policies, and objectives in accordance with Company strategic plans.

Develop and execute robust end to end Quality strategy for all products.

Partner with other functions like R&D and supply chain to ensure timely Quality deliveries.

Work internally with Wholesome Story, and externally with associated third-party contracts, to ensure appropriate Quality framework is in place to ensure end to end Quality compliance for the business.

Work with in-house and external legal counsel to resolve product compliance conflicts, and other issues when ambiguity exists in the regulations by applying risk management principles to ensure consumer and brand protection.

Provide Quality guidance, risk assessment, and management throughout the product(s) lifecycle.

Monitor, interpret and validate current and changing Quality legislation and share potential impact these activities may have on the innovation/ product maintenance.

Participate as an effective member of cross-functional product teams.

Provide coaching, mentoring, and training within leadership and/or quality team(s) as required.

In conjunction with department managers, coordinate cGMP, SOP and related employee training.

Successfully lead/ facilitate internal and external agency audits as required.

Maintains an open channel for communication between various stakeholders.

Maintain specialized product category knowledge.

Perform other duties inherent of the position and any additional tasks as required.

Benefits:

Pay scale: $80K - $100K/year (total compensation including bonus, incentives, etc.)

Fully remote/work-from-home (except for occasional travel requirements)

Medical, dental, life insurance, 401-k retirement matching.

Job Description:

Quality Manager

Location: Remote/Work From Home (some travel required)

Working Situation: Remote

Level: Mid-Senior level (works closely with company leadership team)

We are Wholesome Story, a women’s health and fertility supplement company specializing in products that support hormonal balance. We are looking to add a Quality Manager to our rapidly growing team.

The Quality Manager will play a critical role, responsible for overseeing the company's Quality activities, ensuring compliance with state and federal regulations, and overseeing the day-to-day activities of the Quality department for the company. The Quality Manager will play a key role in shaping the future of Wholesome Story by helping ensure the safety and quality of its products and operations.

The Quality Assurance Manager will:

• Oversee quality operations
• Enforce compliance with cGMP in
• in Operations dept.
• with contract manufacturers.
• Conduct annual manufacturer audits.
• Perform annual internal audits.
• Develop and execute Quality strategies for all products.
• Be responsible for document control and quality improvements.
• Be transparent and require transparency from contract manufacturers.
• Have good people skills and work well in a team environment.
• Travel occasionally to perform audits, attend conferences, etc.
• Perform other duties relevant to the position as required.

The Quality Assurance Manager has the following qualifications:

• Bachelor's Degree, or equivalent experience in relevant fields
• 5-10+ years of relevant experience
• Thorough knowledge and understanding of cGMPs and 21 CFR 111
• Experience conducting risk assessments and gap analyses
• Ability to work well autonomously and within a team in a fast-paced and deadline-oriented environment

Job Type: Full-time

Pay: $80,000.00 - $100,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Vision insurance

Schedule:

• Monday to Friday

Work Location: Remote