Director - Quality, GMP

Apply for this position

Location

Ardsley, NY

Summary

The Director – Quality, GMP is responsible for directing, performing and coordinating CGMP Quality Assurance activities for clinical supplies and commercial product The individual ensures compliance to FDA and other worldwide Health Authority CGMP regulations and guidelines, SOPs, protocols, and industry/internal standards, developing, reviewing and maintaining QA and related inter-departmental procedures and evaluating existing processes for potential improvement.  The Director provides strategic perspective and direction based on expert understanding of Quality, industry history and insights into future directions for commercial product and/or clinical product development which includes manufacturing, testing, and release activities for drug substance, drug product, medical device and packaged/labeled product produced by contract manufacturing sites.

Full Description

*Essential Duties and Responsibilities include the following. Other duties may be assigned.

  • Oversees and performs batch record reviews including QA release of clinical trial materials and marketed drug products.
  • Oversees and performs QA review of CGMP-related documentation, such as specifications, test methods, validation and technical protocols and reports, stability protocols and reports, master and executed production records, deviation/investigation/out-of-specification reports, etc.
  • Collaborates with and provides Quality oversight to Contracted manufacturing and packaging operation partners, including supporting the development and maintenance of necessary Quality Agreements
  • Identifies issues that meet regulatory reporting requirements (i.e. field alert and medical device reports) and participates in internal review by the Quality, Regulatory, and Technical Operations departments, including the Drug Safety and Risk Management, Clinical Development and Medical Affairs departments, as appropriate
  • Authors and demonstrates appropriate Quality oversight of special protocols and investigations resulting from GMP Events including root-cause analysis and assessment of impact to product quality, ensuring appropriate CAPA actions are identified and addressed until closure
  • Directs and implements the GMP Change Control process ensuring alignment amongst stakeholders, implementation of changes consistent with business objectives and QA standards, and timely receipt of deliverables for closure
  • Directs the GMP Audit function, and performs internal and external (domestic and international) audits including report authoring. Evaluates corrective and preventative action responses to audit findings and GMP events for adequacy and timeliness and ensures timely and effective close-out of these actions.
  • Ensures that metrics and trends as well as compliance issues and their resolution are tracked on a periodic basis and presents metrics and trends during management review meetings while assisting in defining performance objectives and supporting preparation of annual product quality reviews
  • Partners with Acorda system owners in identifying business needs and the review and selection of upgrades of document control (EDMS), training / learning (LMS), and quality management (QMS) systems, programs, initiatives, and strategies while helping maintain the validated state of automated systems, and 21 CFR Part 11 compliance.
  • Leads or participates in cross-functional teams to improve processes and procedures
  • Performs or assists with internal and external training of Acorda staff, Contract Manufacturing partners and other 3rd party vendors
  • Assists Head of Quality during FDA or other regulatory authority inspections.
  • Provides strategies to address compliance gaps and identifies enhancements to cross-functional quality systems
  • Authors, maintains and oversees QA approval of Quality Standards and Standard Operating Procedures and other related documentation, such as forms, work instructions, etc.
  • Acts as a key point of contact for Acorda associates, providing information and expert guidance on CGMP regulations and procedures
  • Ensures Quality documentation files, databases and logs are maintained
  • Ensures project deadlines and performance standards are met
  • Ensures compliance with all of Acorda policies and procedures including safety rules and regulations and adherence to budget
  • Conducts presentations on critical quality issues, initiatives and projects at leadership meetings
  • Provides ongoing feedback, development and performance reviews of staff, as appropriate
  • Responsible for training and mentoring associates in the Quality department, as appropriate

  Education and/or Experience:

  •  Bachelor’s degree in life sciences or related field required (advanced degree preferred).
  • Minimum of ten years of experience in pharmaceutical/biopharmaceutical GMP quality assurance environment including five years in a manufacturing environment
  • Minimum of three years hands-on experience with medical devices and related regulations
  • Minimum of three years of management experience
  • Experience in oversight of outsourced manufacturing highly desired
  • Prior experience with internationally (ex-U.S.) market product preferred

  Supervisory Responsibilities:

  •  This individual may supervise associates in the Quality department directly or indirectly.

 Qualifications:

  •  Expert knowledge of API and drug product CGMPs and regulatory health authority regulations and guidance documents.
  • Demonstrates broad and deep expertise related to understanding of the principles and perspectives of regulatory agencies, and quality compliance.
  • Extensive knowledge of FDA, EMA and ICH CGMP requirements regarding manufacturing product quality, deviations, investigations, CAPA, product complaints, field alerts, and product recalls. Must be able to interpret and apply CGMP regulations and Guidance documents independently.
  • Strong knowledge around medical device regulations, including related ISO requirements.

Computer Skills:

  • Must be proficient in MS Office Suite (Word, Excel, PowerPoint, Visio).
  • Experience with electronic quality management and documentation systems.

Certificates, Licenses, Registrations: none required

Other Skills and Abilities:

  •  Must be well organized and demonstrate a keen attention to detail and timelines
  • Excellent written and verbal communication and presentation skills.
  • Must have advanced Problem Solving skills
  • Ability to manage both day-to-day operations as well as project work, adjusting priorities as necessary in a fast paced environment.
  • Ability to work both independently and in a collaborative team setting.
  • Ability to effectively interact with and manage stakeholders at various levels
  • Ability to effectively present information to management and communicate across all levels of the organization
  • Ability to serve on multiple interdepartmental teams and to act as team leader when appropriate
  • Proven ability to manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines.
  • Demonstrated leadership and employee development skills.
  • Demonstrated ability to stay abreast of trends and new information in the industry

Physical Demands:

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

  •  The average travel for this position is 10 % with some variation based upon the demands of the business imperatives. Travel is to both domestic and international locations in support of quality assurance activities.

Work Environment:

 The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

 No specific work demands.

 *To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.