Job Description – Leader, Quality Control

Position Summary:

The Leader of Quality Control is a hands-on individual,

experienced in biopharmaceuticals, that will lead the management of companies Sciences’ quality control laboratory operations, building the capabilities to meet

ISO13485 and cGMP standards from its current foundation in industrial product quality

control businesses. This individual will be responsible for the management of Quality

Control for released products, microbiological testing and environmental

monitoring, customer product testing, and raw materials testing.  Testing will be managed for in-house

resources and at outsourced labs. The program includes laboratory strategy,

equipment/instrumentation selection and implementation, training and team

building, and preparing for and participating in inspections by customers and

regulatory agencies.  The ideal candidate

will be a great team player with a proven track record in biopharma laboratory

operations with excellent organizational talent, outstanding communication

skills, and effective management style.

Responsibilities:

Lead the Quality team under ISO9001, ISO 13485 and cGMP quality systems. Manage proficiency testing of staff.Independently perform hands-on testing as needed utilizing high performance liquid chromatography, dissolution testing, gel electrophoresis, capillary electrophoresis, fragment analysis, endotoxin, FTIR, UV-vis, micro-volume spectrophotometric and fluorometric testing and other quantitative and analytical techniques. Develop, validate, and document analytical methods and standard operating procedures according to specific sample or testing requirements. Collaborate with R&D and other groups to ensure efficient, effective analytical method development and transfer into the QC lab.Manage outsourced testing resources for analytical assays such as next-generation sequencing, mass spec, UHPLC and others which you may recommend. Perform data analysis and interpretation and prepare well-written scientific reports.Qualify new instruments (IQ/OQ/PQ), manage ongoing preventive maintenance programs and participate in software validation as necessary.Work cross-functionally with manufacturing, R&D, sales to complete GMP implementation and to ensure ongoing compliance to quality and regulatory standards.Participate in selection of and working with consultants or other third parties needed to complete the implementation of cGMP/ISO13485 environments and to support ongoing troubleshooting and instrumentation needs.Provide support to management and other teams for regulatory agency inspections, customer visits, and customer sales meetings.Manage the ordering and upkeep of lab equipment, including purchases (price negotiation and installation), and facilitate interactions with equipment vendors for service calls and routine maintenance Maintain appropriate documentation (records and lab notebooks) as required by SOPs.Comply with all cGMP and safety requirements, laboratory SOPs, and company policies and procedures.Prepare reagents, solutions, and standards as required.

Qualifications:  To perform this job successfully, an

individual must be able to perform each essential duty satisfactorily. The

requirements listed below 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.

5+ years of experience executing and leading quality operations in the biopharma / pharmaceutical industry. Master's degree in biology, molecular biology, chemistry or other life science. PhD in a life sciences area preferred.Expertise in nucleic acid (DNA or RNA) manufacturing and quality method development and analytics for HPLC, UPLC, mass specExperience with environmental monitoring and microbiology assays such as endotoxin testing, protein clearanceExperience with ISO9001, ISO13485 and/or cGMP quality systemsComfort in a fast-paced, growth environment, with the demonstrated ability to oversee multiple workstreams and shifting prioritiesStrong collaborator and committed team player, with exceptional organizational, record-keeping and communication skills, both verbal and writtenKnowledge of laboratory safety and associated regulatory guidelines, and experience in handling and managing laboratory chemicals and biological materials, chemical and reagent inventory A deep passion for innovative science and a desire to make a clinical impact in the exciting field of genetic medicineAbility to maintain professional and productive relationships with internal colleagues and external collaboratorsWillingness to learn, teach, and grow in a fast-paced environment Experience with document control systems, databases, Microsoft Office and Google Workspace are preferred.

Competencies: To perform this job successfully, an

individual should demonstrate the following:

Continuous Learning

- Assesses own strengths and weaknesses. Pursues training and development

opportunities. Seeks feedback to improve performance. Shares expertise with

others. Strives to continuously build knowledge and skills.

Customer Service

- Displays courtesy and sensitivity. Meets commitments. Responds promptly to

customer needs. Solicits customer feedback to improve service.

Planning & Organization

- Integrates changes smoothly. Plans for additional resources. Prioritizes and

plans work activities. Sets goals and objectives. Uses time efficiently. Works

in an organized manner.

Problem Solving

- Develops alternative solutions. Gathers and analyzes information skillfully.

Identifies problems in a timely manner. Resolves problems in early stages.

Works well in group problem solving situations.

Teamwork -

Balances team and individual responsibilities. Contributes to building a

positive team spirit. Exhibits objectivity and openness to others' views. Gives

and welcomes feedback. Puts success of team above own interests.

Use of Technology

- Adapts to new technologies. Demonstrates required skills. Keeps technical

skills up to date. Troubleshoots technological problems. Uses technology to

increase productivity.

Quality Management

- Looks for ways to improve and promote quality; Demonstrates accuracy and

thoroughness.

 Eithics

- Treats people with respect; Keeps commitments; Inspires the trust of others;

Works with integrity and ethically; Upholds organizational values.

Language Ability:

Read, analyze and interpret scientific and technical journals, financial

reports and legal documents. Respond to inquiries or complaints from

customers, agencies or members of the business community. Write speeches and

articles for publication.

Mathematical Ability:

Apply advanced concepts such as exponents, logarithms, quadratic equations and

permutations. Apply operations to such tasks as frequency distribution, test

reliability/validity, variance analysis, correlation technique, sampling

theory and factor analysis.

Reasoning Ability:

Define problems, collect data, establish facts and draw valid conclusions.

Interpret an extensive variety of technical instructions in mathematical or

diagram form and deal with several abstract and concrete variables.

Physical Demands:

The physical demands described here are representative of those

that must be met by an employee to successfully perform the essential functions

of this job:

The employee must occasionally lift and/or move up to 25 pounds.

Specific vision abilities required by this job include Close vision, Distance

vision, Peripheral vision, Depth perception and Ability to adjust focus. The

employee is regularly required to sit; use hands to finger, handle, or feel;

reach with hands and arms and talk or hear; smell. The employee is occasionally

required to stand; walk; kneel; crouch.

Work Environment:

This role is required to be on-site.

The above job description is not intended to be an all-inclusive list of

duties and standards of the position. 

Incumbents will follow any other instructions, and perform any other

related duties, as assigned by their supervisor. Reasonable accommodations may be made

to enable individuals with disabilities to perform the essential functions.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.