![ByHeart, Inc.](https://media.trabajo.org/img/noimg.jpg)
Senior Director, Quality Compliance and Systems
vor 1 Monat
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.
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