Senior Compliance Manager

This is an exciting time to join Arena Pharmaceuticals, a clinical stage biotechnology pharmaceutical company with a robust portfolio of assets across multiple therapeutic areas.

We are seeking a Senior Compliance Manager who will be responsible for managing the cGMP external and internal audit programs and supplier qualification process which ensure compliance with regulations and standards set forth by governing regulatory and accrediting agencies. The Senior Compliance Manager will also support the deviation/CAPA system, change management and the supplier corrective action system.

What you’ll dive into

Audit Program

• Performs external GMP compliance audits of Contract Research, Manufacturing, Clinical Supply Depots or Laboratory Testing sites.
• Performs internal GMP audits to ensure compliance to SOPs and regulatory guidelines.
• Manages and maintains the GMP external and internal audit schedules.
• Prepares written reports of observations and recommendations.  Ensures appropriate responses to the observations are received, closed and completed.  Follow-up to ensure observations are closed out.  Assists in developing implementation strategies and assesses effectiveness of corrective actions.
• Assesses and approves audit corrective action plans for internal and external GMP Compliance audits.
• Leads or participates in meetings post internal audits to discuss and drive to closure unresolved issues with auditees, stakeholders and/or Senior Management.
• Peer reviews audit reports written by other Arena auditors and sub-contractors.
• Develops, maintains and reports critical metrics on the audit response process.  Informs Senior Management of adverse trends.
• Identifies gaps in policies and procedures and helps prioritize work based on current regulatory environment, guides and regulations.
• Assists in training of Quality Assurance staff to support the audit program.

Deviation/CAPA Program

• Oversees and maintains the Deviation/CAPA Program.
• Drive Deviations/CAPAs to closure
• Ensures appropriate root cause analysis and corrective actions are documented.
• Sends out monthly reports of past due Deviations/CAPAs and escalates to management as needed. 

Change Control Program

• Oversees and maintains the Change Control Program

Supplier Corrective Action Program

• Oversees and maintains the Supplier Corrective Action Program.

Other

• Serves as a Quality representative on cross-functional teams.
• Develops and implements systems to ensure inspection readiness.
• Assists as required in regulatory inspection activities.  
• Performs any other tasks as requested by Management to support Compliance oversight activities.

What we expect

• BA/BS degree with 8+ years related experience.
• Experience working in GMP-regulated environment is required.
• GMP internal and external audit experience is required.
• Experience working in a virtual environment is preferred.
• Experience managing Deviations/CAPA programs is preferred. 
• Experience with Change Control management is preferred.
• Experience with Supplier Corrective Action is preferred.
• Must possess excellent communication skills, both verbal and written.
• Ability to establish and maintain effective working relationships with coworkers, managers and customers (internal and external) in a positive and collaborative manner.
• Must be able to work under minimum supervision.  
• Must possess proficient knowledge of Microsoft Word, Excel and Powerpoint. 
• The ability to use critical thinking and resolve issues and to deal with a variety of concrete variables in situations where general standardization exists.
• Ability to identify situations which will require management intervention for resolution.  
• Ability to handle multiple projects simultaneously and to prioritize tasks. 
• Strong self-motivation as well as the ability to work independently, and in a team environment.  
• Strong follow up, organization and prioritization skills.
• A highly driven, detailed oriented person is essential for this position.
• Must be able to maintain confidentiality.
• Knowledgeable of federal and other regulations, e.g. 21CFR210, 21CFR211, and European Guidelines.  
• Must be able to travel domestically and internationally up to 25%

What you’ll get

• To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people’s lives 
• Opportunities to learn and contribute creative solutions
• Comprehensive health insurance
• Matching 401k retirement plan
• Paid time off and holidays
• Company celebrations

Arena celebrates and supports our differences and is proud to be an Equal Employment Opportunity and Affirmative Action Workplace. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Arena is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance due to a disability, you may contact us at jobs@arenapharm.com.