Senior Director, Quality Compliance and Systems

1 week ago

Perth, Western Australia ByHeart, Inc. Full time

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

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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