Title:  Manager, QA Compliance - Audits

Job Title: Manager, QA Compliance - Audits

Location: Cherry Hill, New Jersey

Job Type: Full-time

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds.  We are seeking a talented and motivated Manager, QA Compliance - Audits. In this role, you will be responsible for managing and executing QA Compliance related to Internal/External Audits, CAPA Program, Quality Agreements, Complaints Handling, Annual Product Reviews, FARs, Recalls Acts as a designee for Associate Director of QA Systems on as needed basis

Key Responsibilities:

• Assist in facilitating audits conducted by regulatory agencies, customers, and clients
• Manage and execute internal and supplier audit program, prepare yearly audit schedule, and work with Sr QA auditor in conducting audits as per the schedule
• Write and prepare audit reports, responses to the audit findings by regulatory agencies, customers, and clients
• Review audit reports and responses for accuracy and completeness and follow-up on corrective actions and commitments
• Assist/Manage customer complaints program. Review and approve complaint investigation reports and responses as needed
• Responsible for reviewing and approving Quality Agreements
• Assist with FARS and Recalls ensuring compliance
• Assist/Manage CAPA program.  Review and approve CAPAs
• Assist/Manage Annual Product Review program.  Review and approve Annual Product Reviews
• Prepare monthly reports, quality scorecards, trending charts, meeting minutes for the site
• Evaluate and enhance departmental and site procedures to ensure compliance with cGMPs and company policies
• Review and approve change controls, investigations, validation and qualification protocols and reports
• Participate on project teams or in site meetings as directed by Associate Director, QA Compliance
• Assist/Deliver monthly Quality Council/Management Review for the site
• Conduct performance reviews of staff
• Manage within the allocated budget and resources
• Prepare monthly departmental performance report
• Cross-train direct reports to act as a back-up for departmental activities
• Communicate compliance issues to Associate Director, QA Compliance as they arise
• Act as a liaison between all cross functional departments to resolve compliance issues
• Act as a designee for Associate Director, Quality Systems on as needed basis

Qualifications:

We value the skills and experiences candidates bring to the table.  While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

• Minimum:  BS degree in chemistry, biology, pharmacy or related scientific discipline
• Preferred: Advanced Degree in Science or equivalent.
• Highly Preferred : Certification such as ASQ-CQA, Strong background in QC- Chemistry

Experience:

• Minimum: 5-7 years of pharmaceutical industry experience in Compliance/QA/QC of which 2-3 years in a supervisory role. 
• Experience in conducting and facilitating internal, supplier and regulatory audits
• Preferred:   Experience in Sterile manufacturing experience

Skills

• In depth knowledge cGMPs/Regulatory requirements.
• Strong knowledge of QC/QA quality systems including validation.
• Strong analytical, technical and problem-solving skills.

• Excellent People, Communication and Technical Writing Skills

• Excellent interpersonal, communication, influencing, and resolution conflict skills.
• Knowledge of computer programs such as Excel, Access, Power Point, Statistical software

Compensation:

Base Salary: $92,850 to $158,450 annually.  The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process.

What We Offer*:

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay.  Hikma will match 100% of the first 6% of eligible pay that you contribute
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date).  Additional days granted upon reaching work milestone anniversaries
• 3 personal days (prorated based on hire date)
• 11 company paid holidays
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Wellbeing rewards program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment.  Benefits are subject to change as well as specific plan or program terms.

Recruiters:

Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions.  In the absence of a signed agreement and approval from Hikma’s Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.

Equal Opportunity Employer:

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer.  Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.