Quality Assurance / Compliance Officer : Associate Director level or higher
The candidate will be responsible for carrying out several crucial activities in the Quality Systems and Compliance Group by hand.
The chosen applicant is a leader who is self-motivated, self-sufficient, and has broad expertise in prior Quality and / or Compliance responsibilities.
In addition, this role will create, evaluate, and approve important papers linked to the company's quality system and guarantee ongoing compliance.
- 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
Travel Requirements : Up to 20% travel required
Education : BS or MS Pharmaceutics or Related Sciences
Job Type : Full-time
Experience : At least 10 years of pharmaceutical industry experience
Minimum 5 years of hands-on experience in generic pharma industry)
Compensation and Benefits :
- Competitive salary and target annual bonus (based on yearly company and personal performance)
- Medical, Dental, Vision and 401k (no matching)
- Relocation assistance available on a case-by-case basis
Qualifications :
- Experience in generic pharmaceutical development with a good understanding of the drug development process
- Expert knowledge of cGMP, ICH, USP and FDA quality guidelines and regulations
- Effective oral and written communication skills.
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