Director, Quality Operations Syracuse

Bristol Myers Squibb Syracuse , NY 13201

Posted 2 months ago

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development.

Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

This position reports to the Head of Biologics Quality Internal Sites with dotted line to the General Manager

and is located in Syracuse, NY. The role has 6 direct reports including Quality Assurance, Quality Control,

Quality Control Microbiology, Compliance, and Aseptic Quality along with over 100 indirect reports and 20+

onsite contractors. Directs and develops the Quality operations of the Syracuse site ensuring compliance with

Company Directives and Government Regulations; and, to lead the site's interface with worldwide regulatory

authorities governing the manufacture of Biologic Drug Substance. This position ensures that all products are

manufactured, tested, stored and distributed in accordance with regulatory and company standards, guides, and

procedures and meet the requirements of the Domestic and International regulatory agencies. This position also

oversees and audits programs to assure compliance with all principles of current Good Manufacturing Practices,

Company Directives and Government Regulations to avoid costly recalls or other regulatory sanctions. This

position must comply with all Security guidelines, Environmental Health and Safety regulations and the current

Good Manufacturing Practices required by the job function. Job responsibilities include but are not limited to:

Management and leadership of the Quality Unit at the biologics manufacturing site in Syracuse, which

produces commercial biological drug substance.

Develops and maintains partnership with the Site Leadership Team (SLT) to assure that the biological

drug substance manufactured, tested, stored at the site comply with cGMP and global Health Authority

filings.

Working with the SLT, assures that the site is in a state of inspection readiness at all times to achieve

successful outcomes of global regulatory inspections.

Leads efforts to ensure the site operates in compliance with company policies and directives, Health

Authority regulations and evolving expectations.

Establishes the site Quality plan, strategy and objectives. Establishes site quality metrics and reports

monthly performance; develops and advances action plans to achieve targets and drive performance.

In conjunction with the SLT, chairs the site Quality Council and participates in regional Quality Council

to continuously improve the quality and compliance performance profile of the site.

Inspires transformative thinking and motivates employees to deliver benchmark performance.

Works to support product robustness (monitoring) and analytical robustness efforts to improve quality

and compliance.

Provides oversight to QC testing laboratory, with responsibility for raw material, in process and drug

substance release, stability testing.

Where services (such as quality control testing services) are performed for other sites, assures that

quality service levels are established through quality agreements and communication between sites.

Assures robust succession plans for critical positions, actively supports and develops talent at the site.

Leads and fosters an environment of continuous improvement (eg. lean labs, Operational Excellence).

Builds and fosters strong relationships within the biologics quality and global quality network to drive

compliance, strengthen quality systems and support company objectives.

At Bristol-Myers Squibb, we're creating innovative medicines for patients who are fighting

serious diseases. We're also nurturing our own team with inspiring work and challenging career

options. No matter our role, each of us makes a contribution. And that makes all the difference.

Direct all aspects of site quality programs, systems, operations and compliance activities, including,

Quality Control, Compliance, Quality Assurance, and Quality Engineering.

Ensures that appropriate GMP Quality Systems are in place, both through review and approval of

procedures and shop floor presence, as required, and that adequate documentation exists to support and

drive compliance.

Ensures site GMP required procedures are in alignment and compliance with BMS Corporate

Compliance and WWQ&C Headquarters Policies and Directives.

Ensures adherence to the Quality unit responsibility (WWQC 2.1 current version) and provides

leadership accordingly.

Ensures that deviations from procedures and specifications are investigated, resolved and documented;

that corrective/preventative actions are identified and implemented to avoid the occurrence/recurrence of

deviations and that no materials are released before the completion of the investigation.

Lead recalls, market withdrawals, and other regulatory actions when authorized by the Sr. Vice

President Worldwide Quality & Compliance or as required by local regulatory agencies.

Interfaces with Regulatory Agencies (FDA, EMA and foreign regulatory agencies) as necessary, leads

site regulatory inspections and ensure compliance with the marketing authorization requirements.

Interface directly with suppliers and customers, as well as Technical Operation senior management.

Notify the appropriate levels of management within Quality Operations Senior Management of

significant quality issues immediately.

Ensure that all departments have knowledge regarding the roles, responsibilities and authority of the

Quality Unit.

Ensure an effective process/system for disposition of raw materials, API's, packaging and labeling

materials and the involvement in the decision for Bulk Drug Substances disposition.

Chair the site Quality Council in conjunction with the General Manager.

Anticipates regulatory trend and establishes systems to adhere to GMP compliance for the site and

Company.

Monitor implementation plans for any new Quality Policies, Directives and associated impact

assessments.

Issue/approve/communication of Biological Drug Product Reports per established timelines.

Approve CAPA and investigation extensions.

Stop manufacturing activities as appropriate.

Ensure an effective process is in place for reserve sample collection and storage.

Ensure the appropriate information to and obtain the Qualified Person's approval as required by the

specific European Union (EU) regulatory authorities is provided.

Ensure that all process, product and computer systems validation protocols and reports, change control

documentation, redressing / reprocessing / rework operations, Investigation reports related to

manufacturing process and microbiology laboratory, and Annual Product Quality Review (APQR's)

elements are revised and approval.

At Bristol-Myers Squibb, we're creating innovative medicines for patients who are fighting

serious diseases. We're also nurturing our own team with inspiring work and challenging career

options. No matter our role, each of us makes a contribution. And that makes all the difference.

Ensure that an adequate Change Control Program is established.

Assess benefits and cost of all areas of Quality Operations and regulatory Compliance to minimize risks

to the Company.

Ensures budgets development and the preparation of periodic projections of spending against budgets;

and manages and controls departmental spending.

Ensure that all incoming personnel have adequate training, education, and experience to perform their

GMP related job functions effectively.

Ensure Master Validation Plan (MVP) compliance.

Approve or reject specifications impacting drug products, raw material or packaging components.

Ensures that all current vendors are qualified and conduct audits of approved Third Party Manufacturers

and other vendors at defined frequencies as part of the vendor monitoring process as part of the Supplier

Management Program.

Ensure manages the product complaints that include performing complaint investigations in a timely

manner, instituting corrective actions where appropriate and identifying product complaint trends.

Ensure that qualification/calibration of laboratory equipment is conducted following applicable

procedures.

Ensure that a process/sampling program is in place.

Ensure Records Retention program in the functional Department.

Support product submission documentation.

Ensure the completion of Annual Product Quality Review Report elements as established in

products/systems schedule.

Uses results of testing performed in the incoming materials area, analytical, and microbiological

laboratories and vendor documentation for the disposition of materials.

Ensures all necessary testing is carried out.

Issues and prepared laboratory or notice of events (NOE) investigations using TrackWise system as

needed.

Ensures an effective process/system is in place for disposition of materials.

Verify consistency with other site procedures and/or specifications.

Verify compliance with BMS Policies and Guidelines.

Assures that adequate documentation exists to support and drive compliance.

At Bristol-Myers Squibb, we're creating innovative medicines for patients who are fighting

serious diseases. We're also nurturing our own team with inspiring work and challenging career

options. No matter our role, each of us makes a contribution. And that makes all the difference.

POSITION QUALIFICATIONS:

BS. in Biology, Chemistry, Engineering or similar; advanced degree (Masters or PhD) preferred

Minimum of 12 years experience in the biopharmaceutical industry

Direct experience disposition of product and leading sites through HA inspections ideal

Demonstrated leadership experience; able to lead a large organization and work in cross functional

teams; demonstrated ability to make and act on decisions while balancing speed, quality and risk.

Significant knowledge of biologics manufacturing, QA, Validation, QC, Regulatory Affairs and

technology transfer

Ability to think clearly and in a decisive manner; remain calm under adverse conditions

In- depth knowledge of quality systems principles and applications

Excellent oral and written communication skills

Demonstrated ability to work independently and with teams in a dynamic and complex environment

Ability to work in a matrix environment and build strong relationships by being transparent, reliable and

accountable

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.



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Director, Quality Operations Syracuse

Bristol Myers Squibb