Director, Process Support & Quality Control

Cambrex•Charles City, IA

About The Position

The Director Quality Control is accountable for the overall management of Process Support, Raw Materials, Quality Control, and Stability operations at the site. The Director will ensure that all operations are conducted in compliance with cGMP regulations, relevant compendial requirements, company policies, standards and procedures and safety standards. The Director will ensure that lab systems and resources are appropriately organized and managed to support accurate and timely completion and approval of results, validations or transfers to ensure client, customer and project needs are delivered in the most efficient and optimal manner.

Requirements

Demonstrated, well developed analytical and problem-solving skills
In depth knowledge of requirements of GMP Regulations and guidance of US-FDA, EU in particular data integrity and various compendia (USP, EP, JP)
Technical understanding of instrumentation, computerized systems and method validation
Ability to serve as a subject matter expert with clients and regulatory bodies for quality issues/investigations
Detail focused and strong attention to detail and accuracy
Strong presentation skills
Adaptable and flexible in response to a dynamic operating environment
University Bachelor’s degree in Science with a major in Life Sciences, Biochemistry, Chemistry or Pharmacology with at least 15 years of experience in GMP positions with progressive experience in Biologics/Biopharmaceutical/Pharmaceutical industry or Master’s degree with 12 year’s experience in GMP positions, or Ph.D degree with at least 10 years in GMP positions
Minimum 7 years’ experience in a Supervisory role in either Quality Assurance or Quality Control
Technical background, direct experience and understanding of HPLC/UPLC, UPLC-MS, GC, ICP-OES, IC, and FTIR.
Technical background understanding of analytical methods and method validation including technology transfers
Strong understanding of product stability program requirements and development
Strong understanding of statistics supporting analytical assays, trending and stability programs
Track record of achievement in ensuring lab execution efficiency and consistency including LEAN concepts
Experience with industry specific computerized applications including design and implementations (e.g. Labware, Lab instrument applications, LIMS and ELN)
Experience in interacting with Regulatory Inspectors/Investigators inclusive of developing Regulatory responses and dossier sections
Experience in teaching, mentoring and assisting others in learning
Job may require flexibility in work schedule to support the operations
Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration.
All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.

Responsibilities

Manage and direct the overall site Quality Control laboratories (Raw Material, Process Support, and Quality Control) to deliver accurate and timely testing results
Oversee the Stability and Reference Standard programs
Direct the implementation and consistent execution of controls for data integrity, documentation, sample management, reagent and reference standard management, instrument and equipment management controls.
Develop and maintain a high skilled and agile team of analysts and personnel to support optimal service delivery and maintains high levels of compliance and inspection readiness
Manage and direct site implementations of key laboratory management systems including LIMS, ELN, CDAS, and reference standard management tools
Work closely with Quality Assurance to ensure implementation of the requisite controls to assure data integrity
Review and approve instrument and method qualification/validation and transfer protocols and reports, ensuring that the appropriate quality standards have been incorporated and affirmed during the execution of these studies.
Manage, in collaboration with all stakeholders, the QC activities that affect production and validation activities. Anticipate and resolve issues to attain required deadlines and ensure continual communication of status
Manage the Deviation program process within the laboratories that ensures thorough and timely investigations are completed to correctly identify root causes and develop and implement robust and comprehensive CAPAs
Administer appropriate escalation of critical events to Senior Leadership and ensure close communication with clients on quality issues potentially impacting their product or process.
As needed, directly assist in site critical investigations
Interface directly with client stakeholders for quality or compliance issues associated with lab operations and testing
Oversee and manage lab change control program; review and provide input to change controls
Oversee compendial review program to ensure site methods align with current compendia and ensure adequate assessment of potential impacts to qualified methods is assessed as part of this review
Review and approve SOPs as required
Oversee and manage departmental performance and quality metrics
Develop and mentor staff
Prepare and manage departmental budgets, monitor and control spending
Oversee the purchase, use, and maintenance of various analytical instrumentation
Assist Project Management in developing resource and cost structures for client project proposals and statements of work
Performs all other related duties as assigned