Title:  Manager, Quality Assurance

Job Title: Manager, Quality Assurance

Location: Dayton, NJ

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 Quality Assurance Manager to join our team.  In this role, you will be responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that products are manufactured in compliance with cGMP guidelines, USP and FDA, EU requirements. In addition, you will be responsible to direct batch record review, control and release, handle investigation process (CAPA) assuring that any discrepancies are investigated thoroughly and in a timely manner.

Key Responsibilities:

• Regular and predictable onsite attendance and punctuality.
• Directs the batch record review process. Makes final accept/reject disposition on product lots.  Assures batch is manufactured in compliance with NDA/ANDA/EU, cGMP and Validation parameters. Ensures that records are reviewed and released in a timely manner.
• Coordinates communication for status of lots and status of and resolves issues related to accept/reject disposition of batches.
• Places lots on HOLD if Quality issues are detected and notifies senior management.
• Coordinates destruction of rejected finished goods and assures destruction occurs in a timely manner.
• Expedites and prioritizes product releases by coordinating the Review, testing, and releases with site management to meet customer service requirements.
• Conducts routine investigation and departmental meetings to facilitate the performance of release function. 
• Manages personnel for in-process filling and inspection/packaging monitoring
• Provide QA oversight of Operation for the entire Manufacturing process, supporting Clean room technicians and production technicians as needed to identify and address product quality compliance issues as they arise.
• Provide training and assistance to all Clean room and operation personnel for NCR, CAPA and Change Control.
• Provides QA review and approval of manufacturing investigations assuring timely review, follow-up, tracking and trending of MIRs. Perform Root Cause analysis and assure corrective action (CAPA) implementation associated with manufacturing investigations. Provide guidance to the investigation scientists on reporting and metrics required for different levels within organization.
• Performs QA review and approval of LIR’s (Laboratory Investigation Reports). 
• Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR’s, Commissioning Documents, FAT’s), engineering documents.
• Establish a qualification and Requalification program for Clean Room Certification and Recertification, for ISO 5 and 7 environments.
• Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff.
• Assists the QA management in developing on department budget.
• Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions.
• Manages attendance records for all direct reports.

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:    Bachelor’s degree in Pharmacy, Biology, Chemistry or a related field

• Preferred are beneficial [List the required qualifications such as education, skills, and experience]

Preferred Qualifications:

• Additional college courses in Microbiology, cGMPs, Statistics or Quality Management

Skills:

• Must have history of strong documentation skills and attention to detail
• Familiarity with cGMPs and CFR for US and EU
• Excellent organizational skills and ability to multi-task and perform work in a timely manner
• Demonstrates ability to lead a department, projects and meetings effectively
• Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management
• General computer skills and ability to prepare presentations and address large groups
• Demonstrated attention to details and accuracy

• The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must

Compensation:

Base Salary: $ ,000 to $ ,000 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.