Manager/Associate Director, Quality Assurance

Manager, Quality Assurance

Reporting to the Vice President, Quality, the Manager, Quality Assurance (QA) is responsible to maintain and improve Quality Systems and infrastructure appropriate for compliance with GMP system requirements. The Manager, QA serves as the Quality point-of-contact for GMP Systems supporting contract GMP QC testing. The Manager QA manages the approval for release of data and products to meet regulatory compliance, customer and internal requirements. The ideal candidate will have strong communication skills, high energy level and be very self-motivated with a strong sense of commitment to take ownership of projects.

Key Responsibilities

• Manage the GMP group to achieve long and short-term goals and objectives, developing and delivering related training.
• Manage quality systems including change control, deviation/investigation/CAPA, and internal audit program.
• Supervise quality activities including quality assurance, quality systems, documentation control, associated staff, as well as managing inspections and audits.
• Serve as on-site contact for regulatory inspections and customer audits, prepare the site for inspections and audits, coordinate responses to audit findings and monitor the completion of corrective and preventive actions.
• Review changes to global regulatory requirements and industry best practices and facilitate implementation through new or revised processes.
• Develop and obtain executed Quality Agreements with vendors and clients.
• Manage the qualification of suppliers and confirm that procurement specifications are being met.
• Provide quality input to support projects in maintaining required compliance and to provide awareness and preparation for agency inspections.
• Review and approve company procedures, reports, test methods, validation plans and other documents as appropriate to ensure compliance with regulatory requirements.
• Promote a GMP and Quality mindset at all levels within the company.
• Communicate issues and questions to and from staff and management.
• Work with the Medical Director to assure proper oversight for all work relating to clinical testing and ensuring compliance with the Clinical Laboratory Improvement Amendments (CLIA).

Job Requirements

Education and Experience

• B.S./M.S. in science related field with a minimum of 8 years of QA or Compliance experience supporting GMP operations in the pharmaceutical or biopharmaceutical industry.
• Preferred 5 years supervising staff members of a Quality department.
• Preferred 5 years of implementing, conducting, and managing quality assurance audits.
• MasterControl experience a plus.
• ASQ CQA a plus.
• ASQ MQOE a plus.

Skills

• Understanding of ICH, FDA and EMA regulatory and/or guidance documents as well as US and international pharmacopeia, as related to quality assurance activities.
• Understanding of all regulations associated with the Clinical Laboratory Improvement Amendments (CLIA) in support of clinical testing.
• Proven understanding and strong working knowledge of quality risk management.
• Experience in establishing inspection readiness.
• Ability to anticipate and adjust to rapidly changing priorities and anticipate the impact of the change.
• Ability to think strategically and to quickly analyze complex circumstances and problems and to drive appropriate decisions and actions.
• Demonstrated ability to develop and implement processes and process improvements.
• Effective technical writing skills.
• Ability to manage multiple projects in the pharmaceutical industry or contract laboratory environment.
• Ability to implement quality systems and process improvements.
• Ability to provide guidance to clients on compliance issues.
• Supervisory skills in resource allocation, hiring and recruiting.
• Strong leadership skills especially interpersonal and communication skills.

About Prolytix

Prolytix, formerly Haematologic Technologies (HT), is a leading provider of analytical and bioanalytical services to support the research, development, and commercialization of large molecule biotherapeutics and reagents for coagulation research. Prolytix builds on 30 years of expertise to identify and solve the most complex large molecule challenges. Prolytix’s expertise in protein biochemistry supports biotherapeutics from discovery through commercial release, with biopharma services all performed in fully compliant, FDA-inspected GMP facilities. The company also provides expertise in plasma proteins, hemostasis, and blood coagulation and is a leading global supplier of coagulation research reagents (plasma proteins and antibodies), custom formulated IVD/POC device reagents, as well as customized blood collection tubes to support clinical trials. Visit us at goprolytix.com.

Job Types: Full-time, Part-time

Pay: $93,000.00 - $130,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible schedule
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work Location: In person

Salary : $93,000 - $130,000