Qureos Mentor

Kindeva Drug Delivery

Our Work Matters
 At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
 The Impact You Will Make
 The key role of Quality Compliance is to establish and maintain Kindeva’s internal compliance programs. The candidate shall assure effective coordination of internal audits, regulatory inspections, customer audits, regulatory/customer responses/inquiries, corporate initiatives, Compendia, Medical Device Standards, DEA compliance, and Quality Standard assessments to support business needs in a compliant manner. Maintain positive and cooperative communication and collaboration with all levels of employees, customer, contractors and regulators.
 Works closely with other departments to ensure CAPAs/action items to these systems and processes are completed on time and any corrective or preventive actions are put into place in a timely manner. Oversee the Notification to Management process.
 
Essential Job Functions: 
<ul>
<li>Ensures that appropriate systems are in place to meet or exceed the requirements of the company and the regulatory authorities for the quality of the products manufactured on site.</li>
<li>Ensures that current GMP standards, as they apply to the individual products and the site are in compliance with and regulatory standards.</li>
<li>Ensures compliance and Compendial Compliance corporate initiatives.</li>
<li>Notify management and end users of any issues with Quality Compliance, per site procedures.</li>
<li>Implement and improve Internal Audits, and various Compliance Programs.</li>
<li>Review and approve internal audit schedule on an annual basis.</li>
<li>Manage Controlled Substance Program ensuring compliance with DEA regulatory requirements</li>
<li>Review and approve documents, including SOPs.</li>
<li>Coach and develop colleagues towards achieving high performance.</li>
<li>Support the preparation for and management of quality related audits conducted by Corporate, customers and regulatory agencies.</li>
<li>Act as the interface with auditors and Regulatory Agency inspectors as the Quality Subject Matter Expert (SME) for Quality Compliance.</li>
</ul>
Basic Qualifications: 
<ul>
<li>Bachelor’s degree in Pharmaceutical Science, Laboratory Sciences, Engineering or equivalent</li>
<li>7+ years’ experience in the pharmaceutical and/or medical device manufacturing industry</li>
<li>3+ years’ experience in DEA compliance</li>
<li>Previous Supervisor/Managerial experience</li>
<li>Prior auditing experience</li>
<li>Understanding of Medical Device Safety Risk Management (ISO 14971, ISO 62304, IEC 60601-1:2005, etc.)</li>
<li>Proficient interpreting of FDA, EMA, MHRA, and Rest of World cGMP regulations for pharmaceuticals and/or device</li>
<li>Knowledge of Regulatory Compliance</li>
</ul>
Preferred Qualifications: 
<ul>
<li>Master’s degree in Pharmaceutical Science, Laboratory Sciences, Engineering or equivalent</li>
<li>Lead Auditor certification (CQA/ASQ/ISO)</li>
<li>Experience with preparation and/or facilitation of regulatory inspections (FDA, EMA, etc.)</li>
</ul>
California residents should review our Notice for California Employees and Applicants before applying.
 
Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.
 
Equal Opportunity Employer: 
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
 
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Manager, Quality Compliance

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Kindeva Drug Delivery

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Manager, Quality Compliance