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Senior Director, Quality Compliance and Systems
Company
ByHeart
Location
New York, NY
Other
Operations
ROLE DESCRIPTION
We're seeking a highly skilled Senior Director of Quality Compliance & Systems to ensure our products meet the highest standards and exceeds regulatory expectations. The position is remote and has a broad objective of providing strategic leadership in Quality Compliance and building best in class Quality Systems.
Reports To: Chief Quality Officer
Location: Remote
ROLES & RESPONSIBILITIES
Skills & Qualifications
Additionally, you will be eligible for a discretionary performance based annual cash bonus and to participate in our company's equity program, plus our robust medical, dental, vision, retirement, and other benefits.
We're seeking a highly skilled Senior Director of Quality Compliance & Systems to ensure our products meet the highest standards and exceeds regulatory expectations. The position is remote and has a broad objective of providing strategic leadership in Quality Compliance and building best in class Quality Systems.
Reports To: Chief Quality Officer
Location: Remote
ROLES & RESPONSIBILITIES
- Leads and manages a team that oversees quality compliance and quality systems for Byheart, end to end scope from development, manufacturing and distribution of baby formula
- Responsible for internal and external audits of ByHeart operations and distribution network to ensure compliance to internal and external requirements
- Proactively partner with R&D and Operations to developing and maintaining best in class quality systems
- Collaborates cross-functionally to drive quality system integration into product development processes
- Responsibility for successful design, implementation and execution of any strategic quality system improvements
- Effectively collaborates across all operational and commercial functions including suppliers, Third Party Manufacturers (TPM) to ensure product compliance to market, regulatory, and ByHeart requirements
- Engages with external groups including Regulators, Key Opinion Leaders (KOL's) and Industry Groups
- Establish and maintain relationships with regulatory agencies, proactively engages with agencies to promote effective communication, interaction and collaboration
- Maintains detailed understanding of regulatory landscape, responsible for implementing proactive strategy and policy change where appropriate
- Develop and implement risk assessment frameworks to proactively identify and mitigate compliance issues
- Drive continuous improvement initiatives to enhance regulatory compliance
- Coordinate responses to regulatory inquiries and inspections, ensuring prompt information cascade
- Share responsibility for all aspects of quality compliance ensure that there is no major supply disruption due to quality compliance or related issues
- Develop and implement training programs to enhance regulatory awareness across departments
- Lead crisis management efforts related to regulatory issues, providing guidance on swift and compliant resolutions
- Ensures leadership continuity through talent management and succession planning to establish and maintain an industry leading quality compliance and systems team.
Skills & Qualifications
- Bachelor's degree in a relevant field required, advanced degree preferred
- Extensive experience (10+ years) in regulatory compliance within the food, pharma or infant nutrition industry
- Experience with manufacturing and control of powdered infant formula
- Experience with aseptic processing and sterilization processes
- Proven track record of successful engagement with regulatory agencies
- Ability to effectively interact with and manage suppliers, consultants, regulatory agencies and other external partners
- In-depth knowledge of local, national, and international regulations related to baby formula production
- Strong leadership and interpersonal skills with the ability to influence and guide cross-functional teams
- Excellent analytical and problem-solving capabilities
- Exceptional communication skills, both written and verbal
- Ability to present recommendations and solutions to executive leadership team
- Detail-oriented with a commitment to maintaining the highest standards of quality and safety
- Availability for up to to 30% travel required
Additionally, you will be eligible for a discretionary performance based annual cash bonus and to participate in our company's equity program, plus our robust medical, dental, vision, retirement, and other benefits.