Job Description

Job Description

Job Description

About the Company:

Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.

Job Location:

Nivagen Pharmaceuticals Inc., Sacramento, CA

3900 Duckhorn Dr, Sacramento, CA 95834

About the Job:

Title of the Position: Associate Director level or higher

The responsibilities of the candidate encompass hands-on execution of pivotal tasks within the Quality Systems and Compliance Group. The ideal candidate should demonstrate leadership qualities, self-motivation, the ability to work autonomously, and possess comprehensive experience in prior Quality and/or Compliance roles. Additionally, this role entails the establishment, review, and approval of essential quality system-related documents, ensuring continual compliance at Nivagen.

Responsibilities:

• Enforce GMP compliance
• Provide Quality and Compliance oversight of drug supply operations
• Work closely with regulatory affairs department to ensure quality and compliance issues related to customer complaint, adverse events, quality events, market recalls, and pharmacovigilance reporting
• Prepare for FDA audits
• Lead FDA audits
• Perform 3rd party vendor audits. Vendors including contract manufacturing organization, 3rd party logistics, contract research organization, contract research laboratory, API manufacturer, raw material supplier, primary/secondary packaging material supplier
• Lead audits and interface with customers and regulatory representatives
• Perform vendor qualification for the API, raw material and primary/secondary finished goods
• Draft, review and approve quality agreements between the company and contracted organizations including but not limited to contract manufacturer, contact lab etc.
• Review finished product certificate of analysis from various contract manufacturing organizations
• Release commercial consignments
• Review data logger associated with temperature and humidity exposure for finished good consignments
• Generate, review, and approve all SOPs
• Maintain a full understanding of all company SOPs and policies, along with all cGMP, CFR, and ICH guidance that are applicable to the manufacturing of finished drug products
• Provided SOP training and ensure proper rollout and implementation of SOPs
• Review and approve "Annual Product Quality Report" from partners and 3rd party contact manufacturing organizations
• Perform training and manage training records
• Review and approve internal and external Deviations, change controls, CAPAs and OOS
• Assist RA with documentation for filing
• Implement and manage customer complaints program
• Provide appropriate risk analysis for key stakeholders to make critical decisions
• National and international travel as needed
• Other responsibilities as assigned by the supervisor

Qualifications :

Education/Experience:

• BS or MS Pharmaceutics or Related Sciences preferred
• At least 15 years of pharmaceutical industry experience (Minimum 8 years of hands-on experience in generic pharma industry)

Knowledge, Skills, and Abilities:

• Strong interpersonal and de-escalation skills
• Experience in generic pharmaceutical development with a good understanding of the drug development process
• In-depth knowledge of cGMP, ICH, USP and FDA quality guidelines and regulations and quality management systems
• Effective oral and written communication skills
• Self-driven and highly motivated individual with a proactive approach to quality and compliance
• Strong leadership skills with the ability to influence and inspire others
• Detail-oriented and organized, with the ability to manage multiple tasks and projects simultaneously
• Commitment to maintaining the highest standards of quality and compliance
• Ability to work in a fast-paced and changing environment
• Strong interpersonal and de-escalation skills

Requirements:

• Will be needed to travel up to 20% of the time to audit the CRO's
• Required to attend offshore calls from home with partner companies as needed
• Must live or willing to move to Sacramento Metropolitan Region (Approx. 70 miles' radius)
• Legally authorized to be employed in the United States (S. citizens or national, permanent residents)

Benefits:

• Competitive Salary
• Relocation assistance available
• Competitive salary and target annual bonus (based on yearly company and personal performance)
• Medical, dental and vision coverage
• Paid time off plan
• 401k savings plan

Additional Information:

Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

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