<span ":="" 14px"="">The Quality Systems Director, you will work closely with the VP of Quality and play a critical role in ensuring product quality, regulatory compliance, and continuous improvement within the organization.

<span ":="" 14px"="">Quality Systems Director Key Responsibilities:

<ul "list-style-type:="" square"="">

• <span ":="" 14px"="">Lead the following functions, as a “working manager”:<ul "list-style-type:="" square"="">
• <span ":="" 14px"="">Batch record review and product release;
• <span ":="" 14px"="">Deviations/investigation/CAPAs/Complaints;
• <span ":="" 14px"="">Training; and
• <span ":="" 14px"="">Document control/record management.
• <span ":="" 14px"="">Ensure compliance with all regulatory requirements.
• <span ":="" 14px"="">Drive initial assessment of events as they happen and provide guidance for next steps.
• <span ":="" 14px"="">Develop open and collaborative relationships with Quality, Operations, Supply Chain, Laboratory and Distribution personnel.
• <span ":="" 14px"="">Collaborate with others in all CGMP related functions to ensure there is quality systems support for risk management, remediation, overall QMS improvement, a well as process and performance monitoring of the QMS.
• <span ":="" 14px"="">Quality System Management:<ul "list-style-type:="" square"="">
• <span ":="" 14px"="">Develop, implement, and manage processes to ensure products meet required specifications for quality, safety, and efficacy.
• <span ":="" 14px"="">Set appropriate quality standards and parameters for products.
• <span ":="" 14px"="">Communicate quality standards and parameters to the quality assurance (QA) team, product development team, and other relevant staff.
• <span ":="" 14px"="">Batch Record Review and Product Release:<ul "list-style-type:="" square"="">
• <span ":="" 14px"="">Oversee team who conduct batch record reviews and product release activities. Ensure batch records are reviewed in a timely manner and only quality products are released meeting all specifications and requirements.
• <span ":="" 14px"="">Deviations/Investigations/CAPAs/Complaints<ul "list-style-type:="" square"="">
• <span ":="" 14px"="">Oversee deviations, investigations, CAPA and complaint functions.
• <span ":="" 14px"="">Ensure all deviations, investigations, CAPAs and complaints are acted upon in a timely manner (per procedure).
• <span ":="" 14px"="">Reviews and approves deviations, investigations, CAPAs, and complaints.
• <span ":="" 14px"="">Supplier Quality Management:<ul "list-style-type:="" square"="">
• <span ":="" 14px"="">Oversee the Supplier Quality Management function.
• <span ":="" 14px"="">Ensure only adequate/approved suppliers and vendors are utilized by the company.
• <span ":="" 14px"="">Review and approve all audit reports before finalization.
• <span ":="" 14px"="">Review supplier documentation, processes, and performance.
• <span ":="" 14px"="">Work with procurement and supply chain teams to address supplier-related issues.
• <span ":="" 14px"="">Inspection preparation and management:<ul "list-style-type:="" square"="">
• <span ":="" 14px"="">Assist VP of Quality and other personnel in the hosting and management of regulatory inspection and customer quality audits.
• <span ":="" 14px"="">Risk Management:<ul "list-style-type:="" square"="">
• <span ":="" 14px"="">Apply risk assessment principles to internal processes and supplier relationships.
• <span ":="" 14px"="">Mitigate risks related to product quality, safety, and regulatory compliance.
• <span ":="" 14px"="">Communicate risk-related information to relevant stakeholders.
• <span ":="" 14px"="">Continuous Improvement:<ul "list-style-type:="" square"="">
• <span ":="" 14px"="">Monitor trends in audit findings, quality metrics, and customer feedback.
• <span ":="" 14px"="">Propose process improvements to enhance quality and efficiency.
• <span ":="" 14px"="">Participate in management reviews and contribute to quality objectives.

<span ":="" 14px"="">Quality Systems Director Skills/Competencies

• <span ":="" 14px"="">Robust understanding and proven application of QMS in the life science industry
• <span ":="" 14px"="">Self-motivated, highly collaborative
• <span ":="" 14px"="">Ability to work with ambiguity.
• <span ":="" 14px"="">Self-motivated and a self-starter
• <span ":="" 14px"="">High level of professionalism and confidence to work effectively with employees from all levels of the organization, including senior leaders, functional managers, and the general employee population.
• <span ":="" 14px"="">Proven success in effective communication across all levels of the organization, with the ability to influence key stakeholders.
• <span ":="" 14px"="">Demonstrated strong written and verbal communication skills required.
• <span ":="" 14px"="">Ability to communicate in fast-paced environment with frequent change and challenges requiring daily agility and continual multi-tasking.
• <span ":="" 14px"="">Must be fluent in English.
• <span ":="" 14px"="">Fluency in Spanish, a big plus.

<span ":="" 14px"="">Quality Systems Director Qualifications

• <span ":="" 14px"="">Bachelor’s degree in a relevant life sciences field
• <span ":="" 14px"="">Experience: At least 10 years of hands-on experience within a pharmaceutical or medical device quality unit.
• <span ":="" 14px"="">Manager Experience: At least 5-8 years of manager experience.
• <span ":="" 14px"="">Must be thoroughly familiar with applicable laws, regulations and guidances related to pharmaceutical CGMPs.
• <span ":="" 14px"="">Strong attention to detail,
• <span ":="" 14px"="">Strong analytical and problem-solving skills.
• <span ":="" 14px"="">Software Proficiency: Proficient in document management systems and Microsoft Office Suite.
• <span ":="" 14px"="">Communication Skills: Excellent written and verbal communication skills.

<span ":="" 14px"="">Quality Systems Director Physical Requirements

• <span ":="" 14px"="">Receive instructions through oral and written communications accurately and quickly.
• <span ":="" 14px"="">Convey answers or instructions to other workers accurately and quickly.
• <span ":="" 14px"="">Must be able to lift and move up to a max. of 20 pounds.
• <span ":="" 14px"="">Employee will be subject to dust, noise, fumes and odors.
• <span ":="" 14px"="">The physical activity of this position includes, but is not limited to:<ul "list-style-type:="" square"="">
• <span ":="" 14px"="">Climbing, walking, stooping, kneeling, crouching, reaching, standing, pulling, lifting, grasping, twisting, sitting, feeling, and visual acuity

*Candidate must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.