Associate Director, Compliance and Quality Systems
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb.
Around the world, we are passionate about making an impact on the lives of patients with serious disease.
Empowered to apply our individual talents and ideas so that we can learn and grow together.
And driven to make a difference, from innovative research to hands-on community support.
Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment.
We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
Bristol-Myers Squibb has announced plans for an expansion of its large-scale biologics manufacturing facility in Devens, Massachusetts.
The expansion will create a mammalian cell biologics center of excellence through the introduction of biologics development and clinical trial manufacturing capabilities to the site.
Both represent new capabilities for Devens, a site that in its early years has focused solely on large-scale, bulk biologics manufacturing.
The Devens site currently has an opening for an Associate Director, Compliance and Quality Systems.
Responsibilities include but are not limited to:
Hires, trains, and develops qualified Compliance and Quality Systems Managers and staff.
Ensures that all Compliance & Quality Systems personnel have adequate training, education and experience to perform their GMP related job function effectively.
Directs quality oversight of compliance and quality systems activities including Quality Risk management, auditing, records management, supplier quality, change control, and validation quality system approval.
Participates in regulatory reviews and approvals of the facility and products.
Manages the internal cGMP audit function to ensure that the site meets current regulatory and BMS corporate requirements.
Manages the Supplier Quality Agreements program to ensure that raw materials suppliers, services suppliers and equipment vendors meet applicable regulatory and company requirements.
Serves as a Subject Matter Expert SME for audits and GMP compliance.
Provides training programs for auditing and various GMP compliance topics.
Serves as a valued source of cGMP information to internal and external customers.
Leads global regulatory agency inspections and manages all CAPA/lessons learned.
Provides leadership, guidance and problem solving skills.
Ensures that adequate documentation and records management quality system exists to support and drive compliance.
Ensures that all current vendors are qualified and conduct audits at defined frequencies as part of the vendor monitoring process.
Manages the Quality Council by sponsoring and driving Quality initiatives that directly impact the Site operations.
Oversees all quality metrics tracking.
Manages and provided Quality Review of Annual Product Quality Review Report elements as established in products / systems schedule.
Create, review, approve, and track corrective actions related to internal and external audits.
Ensures compliance with regulatory commitments.
Supports Field Alert reports (FAR) and Biologic Product Deviation Reports (BPDR).
Ensures compliance with applicable BMS Policies, Guidelines and Directives and ensures consistency with other site procedures and/or specifications.
Reviews and approves procedures related to regulatory commitments.
Ensures that the procedures are properly followed and adequate for their use.
Verifies alignment with site procedures and to regulatory commitments.
Liaison for regulatory initiatives.
Supports product submissions Qualifications Knowledge of science generally attained through studies resulting in a B.
S.
, in science, engineering, biochemistry, a related discipline, or its equivalent.
A minimum of 7 years experience in biopharmaceutical quality with an additional 6 to 10 years of increasing management responsibility.
Experience in building and growing an organization is desired Expertise in ICHQ9 and Quality Risk Management Program Implementation is required.
Strong background and demonstrated effectiveness in quality assurance or quality compliance of commercial biologics in a FDA and EMA regulated environment.
Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.
Extensive knowledge of US and EMA GMP regulations and guidance.
Proven experience in Inspection management is required.
Demonstrated leadership, interpersonal, communication, and motivation skills.
Knowledge of SAP, LIMS, Maximo and Trackwise.
Knowledge of Syncade, SmartLab and DeltaV desirable.
Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1501569.
Estimated Salary: $20 to $28 per hour based on qualifications.
One shared journey is moving us forward at Bristol-Myers Squibb.
Around the world, we are passionate about making an impact on the lives of patients with serious disease.
Empowered to apply our individual talents and ideas so that we can learn and grow together.
And driven to make a difference, from innovative research to hands-on community support.
Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment.
We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
Bristol-Myers Squibb has announced plans for an expansion of its large-scale biologics manufacturing facility in Devens, Massachusetts.
The expansion will create a mammalian cell biologics center of excellence through the introduction of biologics development and clinical trial manufacturing capabilities to the site.
Both represent new capabilities for Devens, a site that in its early years has focused solely on large-scale, bulk biologics manufacturing.
The Devens site currently has an opening for an Associate Director, Compliance and Quality Systems.
Responsibilities include but are not limited to:
Hires, trains, and develops qualified Compliance and Quality Systems Managers and staff.
Ensures that all Compliance & Quality Systems personnel have adequate training, education and experience to perform their GMP related job function effectively.
Directs quality oversight of compliance and quality systems activities including Quality Risk management, auditing, records management, supplier quality, change control, and validation quality system approval.
Participates in regulatory reviews and approvals of the facility and products.
Manages the internal cGMP audit function to ensure that the site meets current regulatory and BMS corporate requirements.
Manages the Supplier Quality Agreements program to ensure that raw materials suppliers, services suppliers and equipment vendors meet applicable regulatory and company requirements.
Serves as a Subject Matter Expert SME for audits and GMP compliance.
Provides training programs for auditing and various GMP compliance topics.
Serves as a valued source of cGMP information to internal and external customers.
Leads global regulatory agency inspections and manages all CAPA/lessons learned.
Provides leadership, guidance and problem solving skills.
Ensures that adequate documentation and records management quality system exists to support and drive compliance.
Ensures that all current vendors are qualified and conduct audits at defined frequencies as part of the vendor monitoring process.
Manages the Quality Council by sponsoring and driving Quality initiatives that directly impact the Site operations.
Oversees all quality metrics tracking.
Manages and provided Quality Review of Annual Product Quality Review Report elements as established in products / systems schedule.
Create, review, approve, and track corrective actions related to internal and external audits.
Ensures compliance with regulatory commitments.
Supports Field Alert reports (FAR) and Biologic Product Deviation Reports (BPDR).
Ensures compliance with applicable BMS Policies, Guidelines and Directives and ensures consistency with other site procedures and/or specifications.
Reviews and approves procedures related to regulatory commitments.
Ensures that the procedures are properly followed and adequate for their use.
Verifies alignment with site procedures and to regulatory commitments.
Liaison for regulatory initiatives.
Supports product submissions Qualifications Knowledge of science generally attained through studies resulting in a B.
S.
, in science, engineering, biochemistry, a related discipline, or its equivalent.
A minimum of 7 years experience in biopharmaceutical quality with an additional 6 to 10 years of increasing management responsibility.
Experience in building and growing an organization is desired Expertise in ICHQ9 and Quality Risk Management Program Implementation is required.
Strong background and demonstrated effectiveness in quality assurance or quality compliance of commercial biologics in a FDA and EMA regulated environment.
Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.
Extensive knowledge of US and EMA GMP regulations and guidance.
Proven experience in Inspection management is required.
Demonstrated leadership, interpersonal, communication, and motivation skills.
Knowledge of SAP, LIMS, Maximo and Trackwise.
Knowledge of Syncade, SmartLab and DeltaV desirable.
Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1501569.
Estimated Salary: $20 to $28 per hour based on qualifications.
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